Adalimumab

also known as Humira · ADA · D2E7 · ABP 501 · SB5 · AVT02 · GP-2017 · Humira (Adalimumab) · +33 more

Monoclonal antibody targets TNF via inhibition

Developed for: rheumatoid arthritis · Crohn disease · psoriasis · ankylosing spondylitis · uveitis · ulcerative colitis · psoriatic arthritis · spondyloarthropathy
+65 more
· hidradenitis suppurativa · juvenile idiopathic arthritis · Takayasu arteritis · cardiovascular disorder · pyoderma gangrenosum · Behcet disease · choroidal neovascularization · coronary atherosclerosis · inflammatory bowel disease · mucopolysaccharidosis type 1 · mucopolysaccharidosis type 2 · mucopolysaccharidosis type 6 · osteoarthritis · polyarticular juvenile idiopathic arthritis · sarcoidosis · skin sarcoidosis · type 1 diabetes mellitus · age-related macular degeneration · allergic contact dermatitis · anal fistula · anterior uveitis · arthritic joint disease · arthropathy, erosive · asthma · atopic eczema · autoimmune disease · Behcet syndrome arthropathy · colitis · diabetic retinopathy · enthesitis-related juvenile idiopathic arthritis · focal segmental glomerulosclerosis · generalized pustular psoriasis · HIV infectious disease · inflammatory disease · interstitial cystitis · intestinal obstruction · major depressive disorder · malignant pancreatic neoplasm · meningeal tuberculosis · Netherton syndrome · non-infectious anterior uveitis · obstructive sleep apnea syndrome · ocular cicatricial pemphigoid · oral cavity squamous cell carcinoma · osteoarthritis, knee · palmar fibromatosis · psoriasis-related juvenile idiopathic arthritis · Quinquaud's folliculitis decalvans · relapsing polychondritis · REM sleep behavior disorder · retinitis pigmentosa · sciatica · small bowel Crohn disease · Stevens-Johnson syndrome · thyroid gland undifferentiated (anaplastic) carcinoma · type 2 diabetes mellitus · unspecified juvenile idiopathic arthritis · benign prostatic hyperplasia · enterocolitis · frozen shoulder · lumbar disk disease · myocarditis · perianal Crohn disease · pouchitis · temporal arteritis
Investigated by: Abbott · AbbVie · Eisai Inc. · Assistance Publique - Hôpitaux de Paris · Alvotech Swiss AG · Abbott Japan Co.,Ltd
+256 more
· Innovaderm Research Inc. · Samsung Bioepis Co., Ltd. · Amgen · Chia Tai Tianqing Pharmaceutical Group Co., Ltd. · URC-CIC Paris Descartes Necker Cochin · Chung Shan Medical University · Hvidovre University Hospital · National Institute of Allergy and Infectious Diseases (NIAID) · Shanghai Zhongshan Hospital · Stanford University · Takeda · University Hospital of Saint-Etienne · University Hospital, Tours · University Medical Center Groningen · University of Erlangen-Nürnberg Medical School · University of Pennsylvania · Wake Forest University Health Sciences · Biocad · Bristol-Myers Squibb · Celltrion · Children's Hospital Medical Center, Cincinnati · Cinnagen · Eli Lilly and Company · Glostrup University Hospital, Copenhagen · Janssen Research & Development, LLC · Keio University · Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center · McGill University Health Centre/Research Institute of the McGill University Health Centre · Medical University of Vienna · Montreal Heart Institute · NYU Langone Health · National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · Peking Union Medical College Hospital · Pfizer · Qilu Hospital of Shandong University · Reade Rheumatology Research Institute · Sint Maartenskliniek · The Cleveland Clinic · University Hospital, Gentofte, Copenhagen · University Hospital, Ghent · University of Alberta · University of California, San Francisco · University of North Carolina, Chapel Hill · University of Oxford · University of Sherbrooke · Vanderbilt University Medical Center · Wright State University · ZonMw: The Netherlands Organisation for Health Research and Development · 180 Therapeutics LP · AAP MESSIDOR · ANRS, Emerging Infectious Diseases · Aarhus University Hospital · Abu Dhabi Stem Cells Center · Ain Shams University · Alachua Government Services, Inc. · Alder Hey Children's NHS Foundation Trust · Alesund Hospital · American College of Rheumatology Research and Education Foundation · American University of Beirut Medical Center · Andalusian Public Foundation for Health Research in Seville · Australasian Gastro Intestinal Research Foundation · Autoimmunity Centers of Excellence · Betanien Hospital · Biocon Biologics Inc. · Biogen · Brain & Behavior Research Foundation · Bühlmann Laboratories AG · CARE ARTHRITIS LTD. · CSL Behring · Camillo Ricordi and Jay Skyler · Carol Davila University of Medicine and Pharmacy · Centre for Human Drug Research, Netherlands · Centro de Pesquisa Rubens Siqueira · Chang Gung Memorial Hospital · all 262 on the full record

Regulatory milestones approvals, filings & regulatory actions · 33 recorded

Milestone	Jurisdiction	Brand	Indication	Date	Sentence it was read from
Filed ankylosing spondylitis 1 milestone
Filed	China (NMPA)	—	ankylosing spondylitis	2018-11-13	“announced today that National Medical Products Administration (NMPA, successor to CFDA) has accepted its new drug application (NDA) for adalimumab biosimilar candidate (IBI303).” innoventbio.com ↗
Filed autoinflammatory disease, systemic, with vasculitis 1 milestone
Filed	EU (EMA)	Hyrimoz	autoinflammatory disease, systemic, with vasculitis	2022-06-17	“the European Medicines Agency (EMA) has accepted the application for high concentration formulation 100 mg/mL (HCF) of its biosimilar Hyrimoz ® (adalimumab) for regulatory review.” novartis.com ↗ “the European Medicines Agency (EMA) has accepted the application for high concentration formulation 100 mg/mL (HCF) of its biosimilar Hyrimoz® (adalimumab) for regulatory review.” novartis.com ↗ “The Company's biosimilar adalimumab is also undergoing review by the European Medicines Agency, following a regulatory application submitted in December 2015.” amgen.com ↗ “In June 2022, the EMA and FDA accepted for review Sandoz applications for the high-concentration formulation 100 mg/mL (HCF) of its biosimilar adalimumab.” novartis.com ↗
Filed juvenile ankylosing spondylitis 1 milestone
Filed	China (NMPA)	—	juvenile ankylosing spondylitis	2019-01-24	“Henlius has recently received a New Drug Application (NDA) acceptance from the National Medical Products Administration (NMPA) for its adalimumab HLX03” henlius.com ↗
Filed psoriasis 1 milestone
Filed	US (FDA)	—	psoriasis	2018-01-16	“the US Food and Drug Administration (FDA) has accepted its Biologics License Application (BLA), submitted under the 351 (k) pathway, for proposed biosimilar adalimumab” novartis.com ↗ “filed supplemental applications for the use of adalimumab for patients with moderate and severe psoriasis to the Food and Drug Administration (FDA) in the US” eisai.com ↗ “Proposé par Sandoz, le biosimilaire d'adalimumab (Humira® d'AbbVie) a été accepté, en janvier, par la FDA pour un examen réglementaire.” novartis.com ↗ “Das von Sandoz vorgeschlagene Biosimilar Adalimumab (Humira® von AbbVie) wurde im Januar von der FDA zur Zulassungsprüfung angenommen.” novartis.com ↗ “Sandoz proposed biosimilar adalimumab (AbbVie's Humira ® ) was accepted for regulatory review by FDA in January.” novartis.com ↗ “Biosimilars for adalimumab (US) and pegfilgrastim (EU) filed” novartis.com ↗
Filed psoriasis-related juvenile idiopathic arthritis 1 milestone
Filed	US (FDA)	Hyrimoz	psoriasis-related juvenile idiopathic arthritis	2022-07-21	“FDA has accepted for review its Supplemental Biologics License Application (sBLA) for a high concentration formulation of 100 mg/mL (HCF) of its biosimilar Hyrimoz ® (adalimumab-adaz).” novartis.com ↗ “Alvotech’s Biologics License Application (BLA) for interchangeability between ATV02 and Humira® was accepted by the US Food and Drug Administration (FDA) in February 2022” alvotech.com ↗ “In June 2022, the EMA and FDA accepted for review Sandoz applications for the high-concentration formulation 100 mg/mL (HCF) of its biosimilar adalimumab.” novartis.com ↗
Filed rheumatoid arthritis 1 milestone
Filed	Japan (PMDA)	Humira®	rheumatoid arthritis	2011-09-26	“they have submitted an application in Japan seeking approval of inhibition of structural damage of joints in rheumatoid arthritis as an additional indication for Humira®” eisai.com ↗
Approved Indication not stated 8 milestones
Label expansions (3)	US (FDA)	HADLIMA	—	2022-06-17 – 2023-06-26	fda.gov ↗
Label expansion	US (FDA)	HYRIMOZ	—	2023-03-20	fda.gov ↗
Filed	Other	Adessia	—	2023-02-13	“The product has been submitted for approval by the Egyptian health authorities and is expected to be marketed under the name Adessia.” minapharm.com ↗
Filed	US (FDA)	—	—	2022-01-05	“FDA has accepted for review the supplemental Biologics License Application (sBLA) for a citrate-free, high-concentration (100 mg/mL) formulation of SB5 (adalimumab-bwwd).” organon.com ↗
Label expansions (18)	US (FDA)	HUMIRA	—	2004-07-30 – 2021-02-24	fda.gov ↗
Filed	EU (EMA)	—	—	2017-12-18	“Fresenius Kabi has submitted a Marketing Authorization Application to the European Medicines Agency for its adalimumab biosimilar candidate of Humira®.” fresenius.com ↗
Approved	EU (EMA)	Trudexa	—	2003-09-01	europa.eu ↗
Approved	US (FDA)	HUMIRA	—	2002-12-31	fda.gov ↗

Trials 297 · started per year

today

US approved 2002

EU approved 2003

20002001200220032004200520062007200820092010201120122013201420152016201720182019202020212022202320242025202620272028

Phase	Registry id	Dates	Indication	Sponsor	Status	Outcome
Phase 01 trial
Phase 0	NCT06742606	Jan 2025 → Apr 2026 overdue	—	Ain Shams University	Not yet recruiting	No outcome recorded
Phase 116 trials · 4 met primary
Phase 1	NCT06926478	Oct 2026 → Jun 2027 expected	Stevens-Johnson syndrome, ocular cicatricial pemphigoid	Massachusetts Eye and Ear Infirmary	Not yet recruiting	No outcome recorded
Phase 1	NCT07181694	Mar → Nov 2025 overdue	—	Biocad	Recruiting	No outcome recorded
Phase 1	NCT05884242	May → Aug 2023	—	Janssen Research & Development, LLC	Completed	No outcome recorded
Phase 1	NCT05909852	Jul → Nov 2021	—	Amgen	Completed	No outcome recorded
Phase 1	NCT04514796	Aug 2020 → May 2021	—	Samsung Bioepis Co., Ltd.	Completed	Met primary
Phase 1	NCT04439929	Jul 2019 → Jan 2020	—	Turgut İlaçları A.Ş.	Completed	No outcome recorded
Phase 1	NCT03983876	Jul → Dec 2019	—	Alvotech Swiss AG	Completed	No outcome recorded
Phase 1	NCT03849313	Mar 2019 → Feb 2020	—	Alvotech Swiss AG	Completed	Met primary
Phase 1	NCT03579823	May → Aug 2018	—	Alvotech Swiss AG	Completed	No outcome recorded
Phase 1	NCT03273192	Oct 2016 → Aug 2017	—	Cinnagen	Completed	Met primary
Phase 1	NCT02395055	Jun → Oct 2015	—	Biocad	Completed	No outcome recorded
Phase 1	NCT02326233	Jun → Sep 2015	—	Samsung Bioepis Co., Ltd.	Completed	Met primary
Phase 1	NCT02516774	Dec 2014 → Dec 2015	thyroid gland undifferentiated (anaplastic) carcinoma	Gustave Roussy, Cancer Campus, Grand Paris	Withdrawn	No outcome recorded Stop: Enrollment
Phase 1	NCT00855608	Mar 2009 → Mar 2013	choroidal neovascularization, diabetic retinopathy, uveitis	Rafic Hariri University Hospital	Unknown	No outcome recorded
Phase 1	NCT00650156	Jun → Oct 2007	rheumatoid arthritis	AbbVie	Completed	No outcome recorded
Phase 1	NCT00421642	Oct 2006 → Apr 2008	ulcerative colitis	Mayo Clinic	Completed	No outcome recorded

Phase 1/29 trials
Phase 1/2	NCT07061574	Mar 2026 → Apr 2030 expected	type 1 diabetes mellitus	City of Hope Medical Center	Recruiting	No outcome recorded
Phase 1/2	NCT07258641	Jan 2026 → Dec 2027 expected	Crohn disease, ulcerative colitis	University Medical Center Groningen	Not yet recruiting	No outcome recorded
Phase 1/2	NCT07348588	Jul → Aug 2025 overdue	retinitis pigmentosa	Centro de Pesquisa Rubens Siqueira	Active not recruiting	No outcome recorded
Phase 1/2	NCT02586831	Jun 2024	hypoglycemia, type 1 diabetes mellitus	Camillo Ricordi and Jay Skyler	Withdrawn	No outcome recorded Stop: Enrollment
Phase 1/2	NCT03607903	Jul → Oct 2018	—	Centre for Human Drug Research, Netherlands	Completed	No outcome recorded
Phase 1/2	NCT03153319	Jun 2017 → Jan 2027 expected	mucopolysaccharidosis type 1, mucopolysaccharidosis type 2, mucopolysaccharidosis type 6	Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center	Active not recruiting	No outcome recorded
Phase 1/2	NCT02437253	May 2015 → Jul 2016	mucopolysaccharidosis type 1, mucopolysaccharidosis type 2, mucopolysaccharidosis type 6	Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center	Completed	No outcome recorded
Phase 1/2	NCT01275508	Jan 2011 → Apr 2012	Crohn disease	University of Erlangen-Nürnberg Medical School	Completed	No outcome recorded
Phase 1/2	NCT00686439	Jun 2008 → Nov 2010	osteoarthritis	University of Alberta	Completed	No outcome recorded
Phase 247 trials · 6 met primary
Phase 2	NCT07845604	Sep 2026 → Jul 2031 expected	major depressive disorder	Daniel Moriarity	Recruiting	No outcome recorded
Phase 2	NCT06996652	Aug 2026 → Aug 2029 expected	REM sleep behavior disorder	Yale University	Recruiting	No outcome recorded
Phase 2	NCT07268534	Apr 2026 → Nov 2029 expected	Quinquaud's folliculitis decalvans	Assistance Publique - Hôpitaux de Paris	Not yet recruiting	No outcome recorded
Phase 2	NCT07138898	Dec 2025 → Jan 2028 expected	rheumatic disorder	NYU Langone Health	Recruiting	No outcome recorded
Phase 2	NCT06941376	Nov 2025 → Jul 2027 expected	relapsing polychondritis	University of Pennsylvania	Recruiting	No outcome recorded
Phase 2	NCT07208539	Oct 2025 → Apr 2026 overdue	malignant pancreatic neoplasm	Shanghai Zhongshan Hospital	Not yet recruiting	No outcome recorded
Phase 2	NCT07137858	Aug 2025 → Jun 2027 expected	oral cavity squamous cell carcinoma	Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University	Not yet recruiting	No outcome recorded
Phase 2	NCT06849908	Nov 2024 → Jun 2027 expected	Behcet disease	Peking Union Medical College Hospital	Recruiting	No outcome recorded
Phase 2	NCT03938701	Aug 2024 → Mar 2026 overdue	inflammatory bowel disease, rheumatoid arthritis	University Medical Center Groningen	Recruiting	No outcome recorded
Phase 2	NCT06257875	Mar 2024 → Sep 2027 expected	ulcerative colitis	AbbVie	Active not recruiting	No outcome recorded
Phase 2	NCT05874505	Jul 2023 → Nov 2026 expected	uveitis	Assistance Publique - Hôpitaux de Paris	Not yet recruiting	No outcome recorded
Phase 2	NCT05590455	Apr 2023 → Jun 2027 expected	HIV infectious disease, meningeal tuberculosis	ANRS, Emerging Infectious Diseases	Recruiting	No outcome recorded
Phase 2	NCT05155592	Jan 2021 → Jan 2023	uveitis	Dan Liang	Unknown	No outcome recorded
Phase 2	NCT03651518	Oct 2020 → Nov 2025	autoimmune disease, inflammatory disease	Assistance Publique - Hôpitaux de Paris	Completed	No outcome recorded
Phase 2	NCT04588818	Feb 2020 → Dec 2023	uveitis	Sun Yat-sen University	Unknown	No outcome recorded
Phase 2	NCT03823391	Mar 2019 → Apr 2020	rheumatoid arthritis	AbbVie	Completed	No outcome recorded
Phase 2	NCT03180957	Mar 2016 → Nov 2020	palmar fibromatosis	University of Oxford	Completed	No outcome recorded
Phase 2	NCT02565810	Sep 2015 → Mar 2016	rheumatoid arthritis	Samsung Bioepis Co., Ltd.	Completed	Met primary
Phase 2	NCT02393378	Apr 2015 → Jun 2016	rheumatoid arthritis	Takeda	Terminated	No outcome recorded Stop: Business
Phase 2	NCT02471118	Mar 2015 → Mar 2021	osteoarthritis, knee	CARE ARTHRITIS LTD.	Completed	No outcome recorded
Phase 2	NCT02113904	Jan 2014 → Dec 2016	Netherton syndrome	Assistance Publique - Hôpitaux de Paris	Completed	No outcome recorded
Phase 2	NCT02015793	Dec 2013 → Feb 2015	Crohn disease	AbbVie	Completed	No outcome recorded
Phase 2	NCT01872546	Jan → Apr 2013	psoriasis	Poitiers University Hospital	Completed	No outcome recorded
Phase 2	NCT01752855	Dec 2012 → Oct 2013	rheumatoid arthritis	AbbVie	Completed	No outcome recorded
Phase 2	NCT01561313	Mar → Nov 2012	rheumatoid arthritis	AbbVie	Completed	Met primary
Phase 2	NCT01502423	Jan → Nov 2012	rheumatoid arthritis	AbbVie	Completed	Met primary
Phase 2	NCT01373151	Jun 2011 → Sep 2012	rheumatoid arthritis	CSL Behring	Completed	Met primary
Phase 2	NCT04154852	Jun 2011 → Jan 2017	arthritic joint disease	University of Leeds	Completed	No outcome recorded
Phase 2	NCT01136252	May 2010 → Sep 2011	age-related macular degeneration, choroidal neovascularization	Hospital Universitari Vall d'Hebron Research Institute	Completed	No outcome recorded
Phase 2	NCT02456363	Nov 2009 → Oct 2019	ankylosing spondylitis	Chung Shan Medical University	Unknown	No outcome recorded
Phase 2	NCT00730717	May 2009 → Dec 2010	pyoderma gangrenosum	Wright State University	Withdrawn	No outcome recorded
Phase 2	NCT00731757	May 2009 → Dec 2010	skin sarcoidosis	Wright State University	Withdrawn	No outcome recorded
Phase 2	NCT00918255	Apr 2009 → Mar 2010	hidradenitis suppurativa	Abbott	Completed	Met primary
Phase 2	NCT00814255	Dec 2008 → Jun 2013	focal segmental glomerulosclerosis	NYU Langone Health	Completed	No outcome recorded
Phase 2	NCT00525902	Jan 2008 → Sep 2010	uveitis	Oregon Health and Science University	Completed	No outcome recorded
Phase 2	NCT00514982	Aug 2007 → Mar 2011	Hermansky-Pudlak syndrome, colitis	National Institute of Allergy and Infectious Diseases (NIAID)	Withdrawn	No outcome recorded
Phase 2	NCT00512863	Aug 2007 → ?	asthma	Abbott	Withdrawn	No outcome recorded
Phase 2	NCT00690846	Jul 2007	pyoderma gangrenosum	Wake Forest University Health Sciences	Withdrawn	No outcome recorded
Phase 2	NCT00827996	Feb → Nov 2007	hidradenitis suppurativa	Florida Academic Dermatology Centers	Completed	No outcome recorded
Phase 2	NCT00274352	Sep 2006 → Feb 2012	skin sarcoidosis	Pariser, Robert J., M.D.	Completed	No outcome recorded
Phase 2	NCT00296894	May 2006 → Jan 2009	arthropathy, erosive	University Hospital, Ghent	Completed	No outcome recorded
Phase 2	NCT00311246	Apr 2006 → May 2008	sarcoidosis	University of Chicago	Terminated	No outcome recorded Stop: Enrollment
Phase 2	NCT00185562	Jun 2005 → Jan 2006	osteoarthritis	Stanford University	Completed	No outcome recorded
Phase 2	NCT00470509	May 2005 → Jan 2008	sciatica	University Hospital, Geneva	Completed	Met primary
Phase 2	NCT00235833	Jun 2003 → Oct 2004	rheumatoid arthritis	Abbott	Completed	No outcome recorded
Phase 2	NCT00055523	Apr 2002 → ?	Crohn disease	Abbott	Completed	No outcome recorded
Phase 2	NCT00690911	—	sarcoidosis	Wake Forest University	Withdrawn	No outcome recorded

Phase 2/311 trials · 2 met primary
Phase 2/3	NCT05535738	Nov 2022 → Jan 2027 expected	allergic contact dermatitis	Wei-Che Ko	Active not recruiting	No outcome recorded
Phase 2/3	NCT05172817	Jun → Nov 2021	rheumatoid arthritis	Institute for Developing Science and Health Initiatives, Bangladesh	Unknown	No outcome recorded
Phase 2/3	NCT01385826	Jun 2011 → Nov 2014	juvenile idiopathic arthritis, uveitis	Assistance Publique - Hôpitaux de Paris	Completed	Met primary
Phase 2/3	NCT00538902	Aug 2007 → Jul 2008	rheumatoid arthritis	Abbott	Completed	Met primary
Phase 2/3	NCT00445432	Mar 2007 → Mar 2009	Crohn disease	Abbott	Completed	No outcome recorded
Phase 2/3	NCT00445939	Feb → Dec 2007	Crohn disease	Abbott	Completed	No outcome recorded
Phase 2/3	NCT00348153	Aug 2006 → Sep 2012	uveitis	Heidelberg University	Unknown	No outcome recorded
Phase 2/3	NCT00647400	Apr 2006 → Sep 2007	psoriasis	Abbott	Completed	No outcome recorded
Phase 2/3	NCT00338754	Nov 2005 → ?	psoriasis	Abbott	Completed	No outcome recorded
Phase 2/3	NCT00235105	Mar 2005 → Jun 2007	ankylosing spondylitis	Charite University, Berlin, Germany	Unknown	No outcome recorded
Phase 2/3	NCT00647491	Feb 2004 → Jun 2005	rheumatoid arthritis	Abbott	Completed	No outcome recorded

Phase 3106 trials · 27 met primary · 6 missed
Phase 3	NCT06654882	Jan 2026 → May 2029 expected	polyarticular juvenile idiopathic arthritis	Duke University	Recruiting	No outcome recorded
Phase 3	NCT06100744	Jul 2024 → Sep 2026 overdue	psoriasis-related juvenile idiopathic arthritis	AbbVie	Recruiting	No outcome recorded
Phase 3	NCT06258915	Mar 2024 → Jun 2027 expected	uveitis	Assistance Publique - Hôpitaux de Paris	Not yet recruiting	No outcome recorded
Phase 3	NCT05814627	Jun 2023 → Jul 2026 overdue	rheumatoid arthritis	AbbVie	Active not recruiting	Met primary
Phase 3	NCT05379322	Mar 2023	rheumatoid arthritis	Abu Dhabi Stem Cells Center	Withdrawn	No outcome recorded
Phase 3	NCT05637515	Nov 2022 → Sep 2023	psoriasis	Biocon Biologics Inc.	Completed	No outcome recorded
Phase 3	NCT05495568	Nov 2022 → Aug 2023	psoriasis	Celltrion	Completed	Met primary
Phase 3	NCT04798755	Jan 2022 → Oct 2024	uveitis	Hospital San Carlos, Madrid	Unknown	No outcome recorded
Phase 3	NCT05073315	Oct 2021 → Dec 2022	psoriasis	Amgen	Completed	No outcome recorded
Phase 3	NCT04909801	Sep 2021 → Jun 2023 overdue	rheumatoid arthritis	Bristol-Myers Squibb	Active not recruiting	Missed primary
Phase 3	NCT04705844	Sep 2021 → Sep 2022	—	Alachua Government Services, Inc.	Withdrawn	No outcome recorded
Phase 3	NCT04870203	Jul 2021 → Mar 2027 expected	rheumatoid arthritis	University Hospital, Bordeaux	Active not recruiting	No outcome recorded
Phase 3	NCT04610476	Oct 2020 → Oct 2024	psoriatic arthritis, substance withdrawal syndrome	University of Erlangen-Nürnberg Medical School	Unknown	No outcome recorded
Phase 3	NCT04453137	Jun 2020 → May 2021	psoriasis	Alvotech Swiss AG	Completed	Met primary
Phase 3	NCT04230213	Jan 2020 → Jun 2021	rheumatoid arthritis	Pfizer	Completed	Met primary
Phase 3	NCT04224194	Nov 2019 → Jul 2020	rheumatoid arthritis	Alvotech Swiss AG	Completed	No outcome recorded
Phase 3	NCT04171414	Sep → Nov 2019	rheumatoid arthritis	Celltrion	Completed	No outcome recorded
Phase 3	NCT03849404	Feb → Dec 2019	psoriasis	Alvotech Swiss AG	Completed	Met primary
Phase 3	NCT03311464	Oct 2017 → Aug 2019	pyoderma gangrenosum	AbbVie	Completed	No outcome recorded
Phase 3	NCT02840175	May 2017 → Oct 2019	juvenile idiopathic arthritis	Assistance Publique - Hôpitaux de Paris	Completed	No outcome recorded
Phase 3	NCT03104400	Apr 2017 → Sep 2019	psoriatic arthritis	AbbVie	Completed	Met primary
Phase 3	NCT02904902	Sep 2016 → Sep 2017	hidradenitis suppurativa	AbbVie	Completed	No outcome recorded
Phase 3	NCT02660580	Feb → Dec 2016	psoriasis	Fresenius Kabi SwissBioSim GmbH	Completed	No outcome recorded
Phase 3	NCT02629159	Dec 2015 → Oct 2017 overdue	rheumatoid arthritis	AbbVie	Active not recruiting	Met primary
Phase 3	NCT02632175	Nov 2015 → Apr 2025	ulcerative colitis	AbbVie	Completed	No outcome recorded
Phase 3	NCT03172325	Nov 2015 → Aug 2016	rheumatoid arthritis	Cinnagen	Completed	No outcome recorded
Phase 3	NCT02533375	Sep 2015 → Sep 2016	generalized pustular psoriasis	AbbVie	Completed	No outcome recorded
Phase 3	NCT02581345	Sep 2015 → Apr 2017	psoriasis	Momenta Pharmaceuticals, Inc.	Completed	No outcome recorded
Phase 3	NCT02499783	Aug 2015 → May 2017	Crohn disease	AbbVie	Completed	Met primary
Phase 3	NCT02065557	Oct 2014 → Feb 2020	ulcerative colitis	AbbVie	Completed	Met primary
Phase 3	NCT02150473	Oct 2014 → Sep 2017	rheumatoid arthritis	Heinrich-Heine University, Duesseldorf	Terminated	No outcome recorded
Phase 3	NCT02185014	Aug 2014 → Nov 2017	Crohn disease	AbbVie	Completed	No outcome recorded
Phase 3	NCT02196701	Aug 2014 → Mar 2017	psoriasis	AbbVie	Completed	No outcome recorded
Phase 3	NCT02065570	May 2014 → Jan 2020	Crohn disease	AbbVie	Completed	Missed primary
Phase 3	NCT02167139	May 2014 → Apr 2015	rheumatoid arthritis	Samsung Bioepis Co., Ltd.	Completed	Met primary
Phase 3	NCT02019472	Apr 2014 → Aug 2016	rheumatoid arthritis	Janssen Research & Development, LLC	Completed	Mixed
Phase 3	NCT02114931	Apr 2014 → Apr 2016	rheumatoid arthritis	Amgen	Completed	No outcome recorded
Phase 3	NCT02065622	Mar 2014 → Sep 2019	ulcerative colitis	AbbVie	Completed	Missed primary
Phase 3	NCT01986127	Feb 2014 → Jun 2018	Crohn disease	Sara Varea	Terminated	No outcome recorded Stop: Enrollment
Phase 3	NCT01970488	Oct 2013 → Aug 2014	psoriasis	Amgen	Completed	No outcome recorded
Phase 3	NCT01958827	Sep 2013 → Mar 2015	Crohn disease	AbbVie	Completed	No outcome recorded
Phase 3	NCT01497717	Jul 2013 → Oct 2016	Behcet syndrome arthropathy	Rambam Health Care Campus	Completed	No outcome recorded
Phase 3	NCT01808118	Apr 2013 → Feb 2017	spondyloarthropathy	AbbVie	Completed	Met primary
Phase 3	NCT01646073	Aug 2012 → Dec 2013	psoriasis	AbbVie	Completed	No outcome recorded
Phase 3	NCT01629628	Jul 2012 → Jul 2016	Crohn disease	Tel-Aviv Sourasky Medical Center	Unknown	Met primary
Phase 3	NCT01550965	May 2012 → Apr 2015	ulcerative colitis	AbbVie	Completed	No outcome recorded
Phase 3	NCT01635764	Apr 2012 → Aug 2016	hidradenitis suppurativa	AbbVie	Completed	No outcome recorded
Phase 3	NCT01494857	Jan 2012 → Dec 2013	ulcerative colitis	Clalit Health Services	Unknown	No outcome recorded
Phase 3	NCT01468207	Nov 2011 → Jan 2014	hidradenitis suppurativa	AbbVie	Completed	Met primary
Phase 3	NCT01468233	Nov 2011 → Apr 2014	hidradenitis suppurativa	AbbVie	Completed	Met primary
Phase 3	NCT01295814	Mar 2011 → Jun 2013	interstitial cystitis	ICStudy, LLC	Completed	Missed primary
Phase 3	NCT01235689	Feb 2011 → Nov 2016	Crohn disease	AbbVie	Completed	Met primary
Phase 3	NCT01251614	Dec 2010 → Dec 2013	psoriasis	AbbVie	Completed	Mixed
Phase 3	NCT01148225	Nov 2010 → May 2018	uveitis	AbbVie	Completed	No outcome recorded
Phase 3	NCT01243671	Oct 2010 → Mar 2012	Behcet disease	AbbVie	Completed	No outcome recorded
Phase 3	NCT01166282	Sep 2010 → Nov 2012	enthesitis-related juvenile idiopathic arthritis	AbbVie	Completed	Met primary
Phase 3	NCT01138657	Aug 2010 → Jul 2014	uveitis	AbbVie	Completed	Met primary
Phase 3	NCT01124838	Aug 2010 → May 2015	uveitis	AbbVie	Completed	Met primary
Phase 3	NCT01064856	Feb 2010 → Aug 2011	spondyloarthropathy	AbbVie	Completed	Met primary
Phase 3	NCT01114880	Jan → Sep 2010	ankylosing spondylitis	Abbott	Completed	No outcome recorded
Phase 3	NCT00939003	Jul 2009 → Feb 2011	spondyloarthropathy	AbbVie	Completed	Met primary
Phase 3	NCT00775437	Mar 2009 → Mar 2013	juvenile idiopathic arthritis	AbbVie	Completed	No outcome recorded
Phase 3	NCT00870467	Mar 2009 → Mar 2011	rheumatoid arthritis	Abbott	Completed	Met primary
Phase 3	NCT00853099	Feb 2009 → May 2011	ulcerative colitis	AbbVie	Completed	No outcome recorded
Phase 3	NCT02779114	Jan 2009 → Dec 2017	rheumatoid arthritis	University of Erlangen-Nürnberg Medical School	Unknown	No outcome recorded
Phase 3	NCT00686374	May 2008 → Apr 2017	Crohn disease	AbbVie	Completed	No outcome recorded
Phase 3	NCT00690573	May 2008 → Mar 2010	juvenile idiopathic arthritis	Abbott	Completed	No outcome recorded
Phase 3	NCT00667355	Feb 2008 → May 2009	ankylosing spondylitis	Abbott	Completed	No outcome recorded
Phase 3	NCT00566722	Jan 2008 → Apr 2009	psoriasis	Abbott	Completed	No outcome recorded
Phase 3	NCT01231321	Dec 2007 → Feb 2010	rheumatoid arthritis	Abbott	Completed	No outcome recorded
Phase 3	NCT00573794	Nov 2007 → Dec 2016	ulcerative colitis	AbbVie	Completed	No outcome recorded
Phase 3	NCT00660647	Sep 2007 → Dec 2011	rheumatoid arthritis	University of Aarhus	Completed	No outcome recorded
Phase 3	NCT00513370	Sep 2007 → Sep 2008	psoriasis	Abbott	Completed	No outcome recorded
Phase 3	NCT00927069	Mar 2007 → Sep 2008	psoriasis	Innovaderm Research Inc.	Completed	No outcome recorded
Phase 3	NCT00427921	Jan 2007 → Jan 2008	Crohn disease	Abbott	Completed	No outcome recorded
Phase 3	NCT00409617	Dec 2006 → Jul 2008	Crohn disease	Abbott	Completed	No outcome recorded
Phase 3	NCT00408629	Nov 2006 → Mar 2010	ulcerative colitis	Abbott	Completed	Met primary
Phase 3	NCT00385736	Nov 2006 → Apr 2009	ulcerative colitis	Abbott	Completed	Met primary
Phase 3	NCT00348283	Aug 2006 → Sep 2008	Crohn disease	Abbott	Completed	Missed primary
Phase 3	NCT00338650	Jun 2006 → May 2007	Crohn disease	Abbott	Completed	No outcome recorded
Phase 3	NCT00427362	May 2006 → May 2007	psoriatic arthritis	Abbott	Completed	No outcome recorded
Phase 3	NCT00603993	Mar → Nov 2006	rheumatoid arthritis	Abbott	Completed	No outcome recorded
Phase 3	NCT00478660	Feb 2006 → ?	ankylosing spondylitis	Abbott	Completed	No outcome recorded
Phase 3	NCT00235885	Jul 2005 → ?	psoriatic arthritis	Abbott	Completed	No outcome recorded
Phase 3	NCT00237887	Dec 2004 → ?	psoriasis	Abbott	Completed	Met primary
Phase 3	NCT00105300	Oct 2004 → ?	Crohn disease	Abbott	Completed	Met primary
Phase 3	NCT00195715	Sep 2004 → Mar 2006	Crohn disease	Abbott	Completed	No outcome recorded
Phase 3	NCT00235872	Aug 2004 → Jul 2006	rheumatoid arthritis	Abbott	Completed	No outcome recorded
Phase 3	NCT00195676	May 2004 → Oct 2009	psoriasis	Abbott	Completed	No outcome recorded
Phase 3	NCT00085644	Jan → Dec 2004	ankylosing spondylitis	Abbott	Completed	Mixed
Phase 3	NCT00234936	Dec 2003 → ?	rheumatoid arthritis	Abbott	Completed	No outcome recorded
Phase 3	NCT00195819	Dec 2003 → Oct 2004	ankylosing spondylitis	Abbott	Completed	Missed primary
Phase 3	NCT00195689	Aug 2003 → ?	psoriatic arthritis	Abbott	Completed	No outcome recorded
Phase 3	NCT00647920	Jul 2003 → Apr 2005	rheumatoid arthritis	Abbott	Completed	No outcome recorded
Phase 3	NCT00077779	Jul 2003 → ?	Crohn disease	Abbott	Completed	No outcome recorded
Phase 3	NCT00235859	Jul 2003 → ?	rheumatoid arthritis	Abbott	Completed	No outcome recorded
Phase 3	NCT00234845	Mar 2003 → ?	rheumatoid arthritis	Abbott	Completed	No outcome recorded
Phase 3	NCT00048542	Sep 2002 → Jan 2005	polyarticular juvenile idiopathic arthritis	Abbott	Completed	Met primary
Phase 3	NCT00049751	Sep 2002 → ?	rheumatoid arthritis	Abbott	Completed	No outcome recorded
Phase 3	NCT00448383	Sep 2002 → Nov 2004	rheumatoid arthritis	Abbott	Completed	No outcome recorded
Phase 3	NCT00055497	Aug 2002 → Jan 2005	Crohn disease	Abbott	Completed	Mixed
Phase 3	NCT01070303	Aug 2002 → Dec 2008	Crohn disease	Abbott	Completed	No outcome recorded
Phase 3	NCT00195663	Dec 2000 → Apr 2004	rheumatoid arthritis	AbbVie	Completed	Met primary
Phase 3	NCT00195650	Jul 2000 → May 2011	rheumatoid arthritis	Abbott	Completed	No outcome recorded
Phase 3	NCT00233571	Jun 2000 → Jun 2006	rheumatoid arthritis	Abbott	Completed	No outcome recorded
Phase 3	NCT00195702	Feb 2000 → Sep 2002	rheumatoid arthritis	Abbott	Completed	No outcome recorded

Phase 493 trials · 7 met primary · 8 missed
Phase 4	NCT06390436	Dec 2026 → Dec 2029 expected	uveitis	University Hospital of Saint-Etienne	Not yet recruiting	No outcome recorded
Phase 4	NCT07663526	Sep 2026 → Dec 2028 expected	Crohn disease	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.	Recruiting	No outcome recorded
Phase 4	NCT07699107	Sep 2026 → May 2030 expected	anterior uveitis, juvenile idiopathic arthritis	Nisha Acharya	Not yet recruiting	No outcome recorded
Phase 4	NCT07564505	Aug 2026 → Mar 2029 expected	—	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.	Recruiting	No outcome recorded
Phase 4	NCT07352566	Aug 2026 → Jun 2030 expected	atopic eczema, psoriasis	University of California, San Francisco	Not yet recruiting	No outcome recorded
Phase 4	NCT07663331	Jul 2026 → Feb 2028 expected	uveitis	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.	Recruiting	No outcome recorded
Phase 4	NCT07529925	May 2026 → Apr 2028 expected	psoriasis	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.	Not yet recruiting	No outcome recorded
Phase 4	NCT07510191	Mar 2026 → Dec 2028 expected	Crohn disease	Sixth Affiliated Hospital, Sun Yat-sen University	Recruiting	No outcome recorded
Phase 4	NCT07149792	Jul 2025 → Dec 2026 expected	psoriasis, psoriatic arthritis	Taichung Veterans General Hospital	Recruiting	No outcome recorded
Phase 4	NCT06833112	Feb 2025 → Aug 2027 expected	ankylosing spondylitis	The Affiliated Hospital Of Guizhou Medical University	Not yet recruiting	No outcome recorded
Phase 4	NCT06528431	Dec 2024 → Sep 2026 overdue	rheumatoid arthritis	University Hospital of Saint-Etienne	Recruiting	No outcome recorded
Phase 4	NCT06180382	Oct 2024 → Oct 2027 expected	Crohn disease	University Hospital of Saint-Etienne	Recruiting	No outcome recorded
Phase 4	NCT06440629	Aug 2024 → Dec 2027 expected	rheumatoid arthritis	Diakonhjemmet Hospital	Active not recruiting	No outcome recorded
Phase 4	NCT06498089	Jun 2024 → Jun 2026 overdue	Takayasu arteritis	Shanghai Zhongshan Hospital	Recruiting	No outcome recorded
Phase 4	NCT06045754	Apr 2024 → Jun 2027 expected	Crohn disease	Takeda	Recruiting	No outcome recorded
Phase 4	NCT05781152	Jun 2023 → Jul 2028 expected	Crohn disease	Connecticut Children's Medical Center	Recruiting	No outcome recorded
Phase 4	NCT05169593	Sep 2022 → Oct 2027 expected	Crohn disease	Universitaire Ziekenhuizen KU Leuven	Recruiting	No outcome recorded
Phase 4	NCT05510063	Aug 2022 → Apr 2023	psoriasis	Samsung Bioepis Co., Ltd.	Completed	No outcome recorded
Phase 4	NCT05414201	Jul 2022 → Jun 2024	uveitis	AbbVie	Completed	No outcome recorded
Phase 4	NCT05540743	Jul 2022 → Dec 2023	unspecified juvenile idiopathic arthritis	Kasr El Aini Hospital	Unknown	No outcome recorded
Phase 4	NCT05527444	Mar 2022 → Dec 2024	ankylosing spondylitis	Qilu Hospital of Shandong University	Unknown	No outcome recorded
Phase 4	NCT05164198	Jan 2022 → Oct 2024	ankylosing spondylitis	Hanyang University Seoul Hospital	Unknown	No outcome recorded
Phase 4	NCT05151848	Jan 2022 → Jan 2026	Takayasu arteritis	Chinese SLE Treatment And Research Group	Unknown	No outcome recorded
Phase 4	NCT05626348	Dec 2021 → Jun 2025 overdue	rheumatoid arthritis	Qilu Hospital of Shandong University	Recruiting	No outcome recorded
Phase 4	NCT05115903	Dec 2021 → Jul 2024	spondyloarthropathy	University Health Network, Toronto	Unknown	No outcome recorded
Phase 4	NCT05080218	Nov 2021 → Apr 2024	psoriatic arthritis, spondyloarthropathy	Jeffrey Curtis	Completed	No outcome recorded
Phase 4	NCT05015335	Aug 2021 → Jul 2022	non-infectious anterior uveitis	Peking Union Medical College Hospital	Unknown	No outcome recorded
Phase 4	NCT04646187	Mar 2021 → Mar 2026 overdue	Crohn disease, ulcerative colitis	University Medical Center Groningen	Enrolling by invitation	No outcome recorded
Phase 4	NCT04028713	Feb 2021 → Mar 2022	psoriasis	University Hospital, Ghent	Terminated	No outcome recorded
Phase 4	NCT04132388	Aug 2020 → Sep 2022	hidradenitis suppurativa	Wake Forest University Health Sciences	Withdrawn	No outcome recorded
Phase 4	NCT04300686	Mar 2020 → May 2022 overdue	Takayasu arteritis	Shanghai Zhongshan Hospital	Recruiting	Met primary
Phase 4	NCT04222920	Mar 2020 → Sep 2023	rheumatoid arthritis	Reade Rheumatology Research Institute	Completed	No outcome recorded
Phase 4	NCT04194827	Mar 2020 → Dec 2024	rheumatoid arthritis	Reade Rheumatology Research Institute	Unknown	No outcome recorded
Phase 4	NCT04131322	Oct 2019 → Jun 2020	Crohn disease, ulcerative colitis	Andalusian Public Foundation for Health Research in Seville	Terminated	No outcome recorded
Phase 4	NCT04045782	Aug 2019 → Jan 2021	inflammatory bowel disease	Pieter Dewint, MD PhD	Completed	No outcome recorded
Phase 4	NCT03739853	May 2019 → Oct 2024	psoriatic arthritis	University of Oxford	Completed	No outcome recorded
Phase 4	NCT03221621	Jul 2018 → Jul 2022	hidradenitis suppurativa	Erasmus Medical Center	Unknown	No outcome recorded
Phase 4	NCT03505008	Apr 2018 → May 2021	rheumatoid arthritis	Keio University	Completed	Met primary
Phase 4	NCT03220841	Oct 2017 → Sep 2020	Crohn disease, intestinal obstruction	St Vincent's Hospital Melbourne	Unknown	Missed primary
Phase 4	NCT02764762	Apr 2017 → Sep 2020	Crohn disease	Takeda	Completed	No outcome recorded
Phase 4	NCT02852694	Feb 2017 → Jun 2021	Crohn disease	PIBD-Net	Completed	No outcome recorded
Phase 4	NCT02897115	Sep 2016 → Dec 2017	spondyloarthropathy	AbbVie	Terminated	No outcome recorded Stop: Enrollment
Phase 4	NCT02814175	Aug 2016 → Sep 2019	psoriatic arthritis	AbbVie	Completed	Met primary
Phase 4	NCT02714634	Mar 2016 → Mar 2029 expected	rheumatoid arthritis	University Hospital, Strasbourg, France	Recruiting	No outcome recorded
Phase 4	NCT02634541	Jan 2016 → Dec 2017	ankylosing spondylitis	University of Helsinki	Unknown	No outcome recorded
Phase 4	NCT02878161	Jan 2016 → Dec 2019	rheumatoid arthritis	Fen Li	Unknown	No outcome recorded
Phase 4	NCT02256462	May 2015 → Jan 2019	Crohn disease	Schneider Children's Medical Center, Israel	Completed	Met primary
Phase 4	NCT02492217	May 2015 → May 2018	ankylosing spondylitis	NOVA University Lisbon	Completed	No outcome recorded
Phase 4	NCT03306446	Mar 2015 → Mar 2021	—	Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives	Unknown	No outcome recorded
Phase 4	NCT02198651	Jan 2015 → May 2018	rheumatoid arthritis	AbbVie	Completed	Missed primary
Phase 4	NCT02148718	Jun 2014 → Aug 2016	Crohn disease	AbbVie	Completed	No outcome recorded
Phase 4	NCT01893996	Jul 2013 → Jul 2017	cardiovascular disorder, rheumatoid arthritis	Jonathan Graf	Completed	No outcome recorded
Phase 4	NCT02132234	Jun 2013 → Jul 2014	ankylosing spondylitis, hypertensive disorder, psoriatic arthritis	Jagiellonian University	Unknown	No outcome recorded
Phase 4	NCT02035800	May 2013 → Dec 2018	rheumatoid arthritis	University of Sherbrooke	Unknown	No outcome recorded
Phase 4	NCT01866592	Apr 2013 → Aug 2016	cardiovascular disorder, psoriasis	University of Pennsylvania	Completed	No outcome recorded
Phase 4	NCT01895764	Mar 2013 → Apr 2015	ankylosing spondylitis	University Hospital, Tours	Completed	Met primary
Phase 4	NCT01722214	Nov 2012 → Dec 2015	coronary atherosclerosis, psoriasis	Innovaderm Research Inc.	Completed	Missed primary
Phase 4	NCT01609205	Oct 2012 → Sep 2017	rheumatoid arthritis	Hamed Rezaei	Completed	No outcome recorded
Phase 4	NCT01604629	Jul 2012 → Apr 2015	spondyloarthropathy	Spanish Clinical Pharmacology Society	Completed	Met primary
Phase 4	NCT01602302	Jun 2012 → Nov 2020	rheumatoid arthritis	Medical University of Graz	Terminated	No outcome recorded Stop: Enrollment
Phase 4	NCT01644396	May 2012 → Sep 2013	psoriasis	AbbVie	Completed	No outcome recorded
Phase 4	NCT01556672	Apr 2012 → Jan 2016	Crohn disease, psoriasis	Innovaderm Research Inc.	Completed	No outcome recorded
Phase 4	NCT01548768	Oct 2011 → Sep 2019	rheumatoid arthritis	Columbia University	Completed	No outcome recorded
Phase 4	NCT01295151	Aug 2011 → Nov 2015	rheumatoid arthritis	Julia Brown	Completed	No outcome recorded
Phase 4	NCT01405326	May 2011 → Dec 2012	rheumatoid arthritis	The Rheumatological Center of Helsinki	Unknown	No outcome recorded
Phase 4	NCT01270035	Jan 2011 → Jan 2014	rheumatoid arthritis	Keio University	Unknown	No outcome recorded
Phase 4	NCT01382160	Jan 2011 → Jul 2013	rheumatoid arthritis	University Hospital, Tours	Completed	No outcome recorded
Phase 4	NCT01265823	Oct 2010 → Feb 2012	psoriasis	AbbVie	Completed	No outcome recorded
Phase 4	NCT01185288	Sep 2010 → Jan 2013	rheumatoid arthritis	AbbVie	Completed	Missed primary
Phase 4	NCT01162421	Sep 2010 → Jul 2015	rheumatoid arthritis	AbbVie	Completed	Missed primary
Phase 4	NCT01181570	Sep 2010 → Aug 2011	obstructive sleep apnea syndrome, psoriasis	Innovaderm Research Inc.	Completed	No outcome recorded
Phase 4	NCT01088165	May 2010 → May 2013	cardiovascular disorder, psoriasis, type 2 diabetes mellitus	Medical University of Vienna	Unknown	No outcome recorded
Phase 4	NCT00940862	Jul 2009 → Jun 2011	coronary atherosclerosis, psoriasis	Innovaderm Research Inc.	Completed	Missed primary
Phase 4	NCT00972218	Jul 2009 → Jan 2010	Crohn disease, spondyloarthropathy	University of Alberta	Withdrawn	No outcome recorded Stop: Enrollment
Phase 4	NCT00837434	Mar 2009 → Nov 2013	rheumatoid arthritis	National Institute of Allergy and Infectious Diseases (NIAID)	Completed	Missed primary
Phase 4	NCT00796705	Nov 2008 → Oct 2010	rheumatoid arthritis	National Institute of Allergy and Infectious Diseases (NIAID)	Terminated	No outcome recorded Stop: Enrollment
Phase 4	NCT00780793	Sep 2008 → Sep 2011	rheumatoid arthritis	Assistance Publique - Hôpitaux de Paris	Completed	Missed primary
Phase 4	NCT02489760	Jul 2008 → Dec 2015	ankylosing spondylitis	Chung Shan Medical University	Unknown	No outcome recorded
Phase 4	NCT00726804	Mar 2008 → May 2012	spondyloarthropathy	Glostrup University Hospital, Copenhagen	Terminated	No outcome recorded Stop: Enrollment
Phase 4	NCT01072058	Feb 2008 → Feb 2011	ankylosing spondylitis	University of Sao Paulo	Unknown	No outcome recorded
Phase 4	NCT00517296	Jan 2008 → Dec 2014	Crohn disease, anal fistula	Vanderbilt University Medical Center	Completed	No outcome recorded
Phase 4	NCT00480272	May 2007 → Mar 2017	rheumatoid arthritis	Fondazione IRCCS Policlinico San Matteo di Pavia	Completed	No outcome recorded
Phase 4	NCT00420927	Dec 2006 → Jul 2010	rheumatoid arthritis	Abbott	Completed	Met primary
Phase 4	NCT01465438	Nov 2006 → Jun 2011	psoriatic arthritis	Glostrup University Hospital, Copenhagen	Completed	No outcome recorded
Phase 4	NCT00761514	Nov 2006 → Aug 2008	rheumatoid arthritis	Abbott	Terminated	No outcome recorded Stop: Enrollment
Phase 4	NCT00234234	Jan 2006 → Dec 2008	rheumatoid arthritis	University Hospital, Rouen	Completed	No outcome recorded
Phase 4	NCT00216177	Sep 2005 → Jan 2009	rheumatoid arthritis	Hvidovre University Hospital	Unknown	No outcome recorded
Phase 4	NCT01270087	May 2005 → Feb 2007	rheumatoid arthritis	Skane University Hospital	Completed	No outcome recorded
Phase 4	NCT00133315	Sep 2004 → Apr 2007	ankylosing spondylitis, psoriatic arthritis	Hvidovre University Hospital	Completed	No outcome recorded
Phase 4	NCT00696059	Aug 2004 → Jul 2007	rheumatoid arthritis	Hvidovre University Hospital	Completed	No outcome recorded
Phase 4	NCT00234897	Aug 2004 → ?	rheumatoid arthritis	Abbott	Completed	No outcome recorded
Phase 4	NCT00291915	May 2004 → Mar 2007	rheumatoid arthritis	Goupe d'Etudes et de Recherche Clinique En Rhumatologie	Unknown	No outcome recorded
Phase 4	NCT00649922	Oct 2003 → Dec 2004	rheumatoid arthritis	Abbott	Completed	No outcome recorded

Phase not applicable11 trials
—	NCT07398651	Dec 2026 expected	psoriatic arthritis	Tanta University	Not yet recruiting	No outcome recorded
—	NCT07491913	Jun 2025 → Dec 2027 expected	Takayasu arteritis	Marmara University	Recruiting	No outcome recorded
—	NCT06310837	Mar 2024 → Dec 2025	uveitis	Zhongshan Ophthalmic Center, Sun Yat-sen University	Completed	No outcome recorded
—	NCT05305066	Feb 2023 → Dec 2028 expected	rheumatoid arthritis	Marie Hudson, MD	Recruiting	No outcome recorded
—	NCT05503875	Jan 2023 → Dec 2027 expected	psoriasis	Second Affiliated Hospital, School of Medicine, Zhejiang University	Recruiting	No outcome recorded
—	NCT05090124	Nov 2022 → Nov 2024	rheumatoid arthritis	NHS Greater Glasgow and Clyde	Completed	No outcome recorded
—	NCT04378621	Oct 2020 → Sep 2025	depressive disorder, rheumatoid arthritis, subjective cognitive decline	Vastra Gotaland Region	Unknown	No outcome recorded
—	NCT01320293	Mar 2011 → Mar 2015	psoriasis	University of North Carolina, Chapel Hill	Completed	No outcome recorded
—	NCT00814866	Sep 2008 → Sep 2010	rheumatoid arthritis	University of Sherbrooke	Completed	No outcome recorded
—	NCT00497614	May 2006 → Dec 2007	rheumatoid arthritis	University Hospital, Tours	Completed	No outcome recorded
—	NCT01144156	—	small bowel Crohn disease	Rabin Medical Center	Unknown	No outcome recorded

Phase not stated3 trials
—	NCT00650390	—	rheumatoid arthritis	Abbott	Approved for marketing	No outcome recorded
—	NCT00650026	—	rheumatoid arthritis	Abbott	Approved for marketing	No outcome recorded
—	NCT00649545	—	rheumatoid arthritis	Abbott	Approved for marketing	No outcome recorded
Comparator or background therapy188 trials
Phase 0	NCT02252809 Comparator	Nov 2008 → Apr 2009	—	Brugmann University Hospital	Completed	No outcome recorded
Phase 1	NCT07849153 Comparator	Oct 2026 → Jan 2027 expected	—	Biora Therapeutics, Inc.	Not yet recruiting	No outcome recorded
Phase 1	NCT07147257 Comparator	Feb → May 2025	—	Nanjing King-Friend Biochemical Pharmaceutical Co., Ltd.	Completed	No outcome recorded
Phase 1	NCT06291948 Comparator	Aug 2022 → Jan 2023	—	Laboratorios Richmond S.A.C.I.F.	Completed	No outcome recorded
Phase 1	NCT04551352 Background	Oct 2020 → Jul 2022	cutaneous melanoma, mucosal melanoma, uveal melanoma	Hoffmann-La Roche	Completed	No outcome recorded
Show all 188 trials opens the full record — a long page

News releases announcing trial results or a regulatory action · 216

Date	Issuer	Release
2026-10-05	Alvotech Swiss AG	Regulatory FDA approves additional U.S. manufacturing capacity for SIMLANDI®, Alvotech’s biosimilar to Humira® alvotech.com ↗ Following the FDA approval, Alvotech can now manufacture AVT02 drug substance for U.S. commercial supply in either DSM1 or DSM2, providing additional capacity and greater flexibility across its manufacturing operations.
2026-09-28	Meitheal Pharmaceuticals, Inc.	Regulatory Meitheal Pharmaceuticals Announces FDA Approval of High-Concentration Formulation of YUSIMRY®, a Biosimilar to Humira® meithealpharma.com ↗ YUSIMRY ® (adalimumab-aqvh) citrate-free, high-concentration formulation, is approved for nine indications of reference product Humira ® , and is now interchangeable
2026-05-05	AbbVie	Results AbbVie Highlights New Long-Term Data Advancing Treatment Standards in Inflammatory Bowel Diseases (IBD) at 2026 Digestive Disease Week® abbvie.com ↗ It found the switch rate was 14% for risankizumab, compared with 21% for ustekinumab, 30% for vedolizumab, 33% for infliximab, and 36% for adalimumab.
2025-10-20	AbbVie	Results RINVOQ® (upadacitinib) Demonstrated Superiority Versus HUMIRA® (adalimumab) for Primary Endpoint in a Head-to-Head Study in Rheumatoid Arthritis Patients Who Have Failed First TNF Inhibitor abbvie.com ↗ Upadacitinib demonstrated superiority versus adalimumab for primary endpoint of achieving low disease activity (DAS28-CRP≤3.2) and ranked secondary endpoint of remission ( DAS28-CRP < 2.6) at week 12
2025-10-17	Celltrion	Regulatory FDA approves expanded pediatric indications for YUFLYMA® (adalimumab-aaty) and unbranded adalimumab-aaty in the United States celltrion.com ↗ YUFLYMA® (adalimumab-aaty), and its unbranded version, are now approved for two additional pediatric indications – adolescent hidradenitis suppurativa (HS) and pediatric uveitis (UV), in the U.S.
2025-05-27	Organon and Co	Regulatory US Food and Drug Administration (FDA) Grants Interchangeability Designation to Samsung Bioepis and Organon HADLIMA™ (adalimumab-bwwd) Injection organon.com ↗ HADLIMA™ (adalimumab-bwwd) injection, 40 mg/0.4 mL & 40 mg/0.8 mL is now interchangeable with all high- and low-concentration presentations (autoinjector, prefilled syringe, and single-dose vial) of Humira (adalimumab)1,2
2025-05-23	Celltrion	Regulatory Celltrion's YUFLYMA® (adalimumab-aaty) receives FDA interchangeability designation for all its approved dosage forms and strengths celltrion.com ↗ Celltrion, Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted an expanded interchangeable designation for YUFLYMA® (adalimumab-aaty), now including prefilled syringe (40mg) and autoinjectors (40mg and 80mg) presentations.
2025-04-15	Celltrion	Regulatory U.S. FDA grants interchangeable designation to YUFLYMA® (adalimumab-aaty), Celltrion's biosimilar to Humira® (adalimumab) celltrion.com ↗ Celltrion, Inc. today announced that the U.S. Food and Drug Administration (FDA) has designated YUFLYMA® (adalimumab-aaty), as an interchangeable biosimilar to Humira® (adalimumab).
2025-04-10	Samsung Bioepis Co., Ltd.	Results 삼성바이오에피스, 국내 학회서 자가면역질환 치료제 최신 연구 성과 공개 samsungbioepis.com ↗ 결과적으로 아달로체는 축성 척추관절염(axSpA), 류마티스 관절염(RA), 크론병(CD), 궤양성 대장염(UC), 건선성 관절염(PsA)의 국내 환자들에게 새로운 안전성 이슈 없이 효능을 보였으며, 이는 삼성바이오에피스가 이전에 수행한 유관 임상 연구의 결과와 다르지 않았다.
2024-06-13	UCB Pharma	Results New data support the value of CIMZIA[®] for women living with chronic rheumatic diseases throughout pregnancy and post-partum, and for people living with RA and high rheumatoid factor levels ucb.com ↗ An in vitro study found that three different RF antibodies all bound to Fc-containing TNFi adalimumab and enabled the formation of large immune complexes.
2024-05-01	Boehringer Ingelheim	Regulatory US FDA approves Boehringer Ingelheim’s high-concentration, citrate-free formulation of Cyltezo® (adalimumab-adbm) injection prnewswire.com ↗ Boehringer Ingelheim announced today that the U.S. Food and Drug Administration (FDA) has approved the high-concentration, citrate-free formulation of Cyltezo® (adalimumab-adbm) to treat multiple chronic inflammatory diseases.
2024-03-10	Samsung Bioepis Co., Ltd.	Results 삼성바이오에피스, 미국 피부과 학회(AAD)에서 자가면역질환 치료제 2종 연구 결과 발표 samsungbioepis.com ↗ SB5는 미국에서 ‘하드리마(HADLIMA™)’로 판매 중이며, 오리지널 의약품과의 상호교환성(IC: interchangeability) 확인을 위한 임상 4상 연구를 진행했고 금번 학회에서 그 결과를 발표했다.
2024-02-24	Alvotech Swiss AG	Regulatory Alvotech and Teva Announce U.S. Approval of SIMLANDI® (adalimumab-ryvk) injection, the first interchangeable high-concentration, citrate-free biosimilar to Humira® alvotech.com ↗ SIMLANDI is the first high-concentration, citrate-free biosimilar to Humira that has been granted an interchangeability status by the FDA, and will qualify for interchangeable exclusivity for the 40mg/0.4ml injection.
2024-02-23	Teva Branded Pharmaceutical Products R&D, Inc.	Regulatory Alvotech and Teva Announce U.S. Approval of SIMLANDI® (adalimumab-ryvk) injection, the first interchangeable high-concentration, citrate-free biosimilar to Humira® tevapharm.com ↗ SIMLANDI is the first citrate-free, high-concentration biosimilar to be designated interchangeable to Humira in the U.S.
2024-01-19	Alvotech Swiss AG	Regulatory Alvotech Provides Update on Status of Biologics License Applications for AVT02 and AVT04 alvotech.com ↗ Following the FDA inspection, Alvotech received a form 483 with one observation.
2023-11-11	UCB Pharma	Results Post hoc analysis showed meaningful efficacy of certolizumab pegol for RA patients with high Rheumatoid Factor (RF) levels ucb.com ↗ A post hoc analysis from the EXXELERATE trial shows that 65.7 percent of certolizumab pegol-treated patients, and 48.3 percent of adalimumab-treated patients, with rheumatoid arthritis (RA) and high rheumatoid factor (RF) levels achieved low disease activity at Week 104
2023-11-08	Samsung Bioepis Co., Ltd.	Regulatory 삼성바이오에피스, 하드리마(휴미라 바이오시밀러) 美 상호교환성 허가 절차 돌입 samsungbioepis.com ↗ 삼성바이오에피스와 오가논(Organon)은 미국 식품의약국(FDA)에 지난 8월 제출한 휴미라 바이오시밀러 '하드리마(HADLIMA™, 성분명 아달리무맙)'의 상호교환성(Interchangeability) 인증 관련 바이오의약품 변경 허가 신청서(sBLA: Supplemental Biologic License Application)에 대한 사전 검토가 완료돼(accepted for review) 본격 심사 절차에 돌입했다고 밝혔다.
2023-11-07	Organon and Co	Regulatory Samsung Bioepis & Organon Announce FDA Acceptance of Supplemental Biologics License Application (sBLA) for Interchangeability Designation for HADLIMA™ (adalimumab-bwwd), a Biosimilar to Humira® organon.com ↗
2023-10-19	RANI Therapeutics	Results Rani Therapeutics Announces Successful Oral Delivery of Monoclonal Antibody via High-Capacity Pill in Preclinical Study ranitherapeutics.com ↗ The RaniPill® HC successfully delivered adalimumab in all of the subjects.
2023-09-20	Alvotech Swiss AG	Regulatory Alvotech Provides U.S. Regulatory Update on AVT02, a High-Concentration Interchangeable Biosimilar Candidate to Humira® (adalimumab) alvotech.com ↗ Alvotech (NASDAQ: ALVO, or the “Company”), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, announced today that the U.S. Food and Drug Administration (FDA) has accepted Alvotech’s resubmitted Biologics License Application (BLA) for AVT02, a high-concentration, interchangeable biosimilar candidate to Humira® (adalimumab).
2023-08-29	Alvotech Swiss AG	Regulatory Alvotech and Bioventure Announce Approval of AVT02 (adalimumab) in Egypt alvotech.com ↗ We are very pleased with the approval of AVT02 in Egypt.
2023-08-01	Organon and Co	Results Samsung Bioepis & Organon Announce Topline Results from Interchangeability Study of SB5 Humira Biosimilar organon.com ↗ The study achieved all primary endpoints (pharmacokinetic endpoints of AUCtau and Cmax at Week 23-25).
2023-06-28	Alvotech Swiss AG	Regulatory Alvotech Provides Regulatory Update on Second Biologics License Application for AVT02 alvotech.com ↗ Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, announced today that the US Food and Drug Administration (FDA) has issued a complete response letter (CRL) for Alvotech’s second Biologics License Application (BLA) for AVT02, a high-concentration biosimilar candidate for Humira® (adalimumab).
2023-05-24	Celltrion	Regulatory Celltrion USA Announces U.S. FDA Approval of Yuflyma® (adalimumab-aaty), a High-Concentration and Citrate-Free Formulation of Humira® (adalimumab) Biosimilar celltrion.com ↗ Celltrion USA today announced that the U.S. Food and Drug Administration (FDA) has approved Yuflyma® (adalimumab-aaty), a high-concentration (100mg/mL) and citrate-free formulation of Humira® (adalimumab) biosimilar.
2023-05-22	Boehringer Ingelheim	Regulatory US FDA approves the Cyltezo® Pen, a new autoinjector option, ahead of July 1 commercial launch prnewswire.com ↗ Boehringer Ingelheim announced today that the U.S. Food and Drug Administration (FDA) has approved the Cyltezo ® Pen, a new autoinjector option for Cyltezo (adalimumab-adbm), an FDA-approved Interchangeable biosimilar to Humira ® (adalimumab).
2023-04-14	Alvotech Swiss AG	Regulatory Alvotech Provides Regulatory Update on AVT02 Biologics License Application alvotech.com ↗ The CRL noted that certain deficiencies, which were conveyed following the FDA’s reinspection of the company’s Reykjavik facility that concluded on March 17, 2023, must be satisfactorily resolved before the application can be approved.
2023-04-13	Teva Branded Pharmaceutical Products R&D, Inc.	Regulatory Complete Response Letter Received for AVT02 Biologics License Application tevapharm.com ↗ Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) announced that the U.S. Food and Drug Administration (FDA) has issued a complete response letter (CRL) to its partner Alvotech (NASDAQ: ALVO) for the Biologics License Application (BLA) for AVT02, a high-concentration biosimilar candidate for Humira® (adalimumab).
2023-04-03	Sandoz	Regulatory Sandoz receives approval by European Commission for Hyrimoz® (adalimumab) high-concentration formulation sandoz.com ↗ Sandoz, a global leader in off-patent (generic and biosimilar) medicines, today announced that the European Commission (EC) granted marketing authorization in the European Union (EU) for a citrate-free high concentration formulation (HCF; 100 mg/mL) of its biosimilar Hyrimoz® (adalimumab).
2023-04-03	Novartis Pharmaceuticals	Regulatory Sandoz receives approval by European Commission for Hyrimoz® (adalimumab) high-concentration formulation novartis.com ↗ Sandoz, a global leader in off-patent (generic and biosimilar) medicines, today announced that the European Commission (EC) granted marketing authorization in the European Union (EU) for a citrate-free high concentration formulation (HCF; 100 mg/mL) of its biosimilar Hyrimoz ® (adalimumab).
2023-03-21	Sandoz	Regulatory Sandoz receives US FDA approval for biosimilar Hyrimoz® (adalimumab-adaz) high-concentration formulation sandoz.com ↗ today announced that the US Food and Drug Administration (FDA) approved a citrate-free high-concentration formulation (HCF) of its biosimilar Hyrimoz® (adalimumab-adaz) injection.
2023-03-21	Novartis Pharmaceuticals	Regulatory Sandoz receives US FDA approval for biosimilar Hyrimoz® (adalimumab-adaz) high-concentration formulation novartis.com ↗ Basel, March 21, 2023 – Sandoz, a global leader in generic pharmaceuticals and biosimilars, today announced that the US Food and Drug Administration (FDA) approved a citrate-free high-concentration formulation (HCF) of its biosimilar Hyrimoz ® (adalimumab-adaz) injection.
2023-02-13	MinaPharm Pharmaceuticals	Regulatory Minapharm Pharmaceuticals receives regulatory approval from the Paul-Ehrlich Institute for a phase 1 multi-center clinical trial in Germany for its Adalimumab biosimilar minapharm.com ↗ Minapharm Pharmaceuticals and Chemical Industries S.A.E announced today the unconditional approval of a phase 1 clinical trial for its Adalimumab biosimilar through the Paul-Ehrlich Institute (PEI) and the responsible ethical committee.
2023-01-30	Sandoz	Regulatory Sandoz receives positive CHMP opinion for citrate-free high concentration formulation of adalimumab biosimilar sandoz.com ↗ Today’s positive opinion from the CHMP brings us closer to providing a treatment choice to patients that offers increased convenience and a reduction in injection volume.
2023-01-30	Novartis Pharmaceuticals	Regulatory Sandoz receives positive CHMP opinion for citrate-free high concentration formulation of adalimumab biosimilar novartis.com ↗ Today’s positive opinion from the CHMP brings us closer to providing a treatment choice to patients that offers increased convenience and a reduction in injection volume.
2023-01-24	Alvotech Swiss AG	Regulatory Alvotech and Bioventure Announce Approval of AVT02 (adalimumab) as Simlandi in Saudi Arabia alvotech.com ↗ “The approval of Simlandi by the SFDA marks an important milestone for local patients and physicians,” said Ashraf Radwan, Division CEO of GlobalOne Healthcare Holding.
2022-12-22	Alvotech Swiss AG	Regulatory Update on U.S. Regulatory Status of AVT02, Alvotech’s Proposed High-Concentration, Interchangeable Biosimilar to Humira® alvotech.com ↗ Communications from the FDA regarding Alvotech’s application supporting interchangeability of AVT02, including a Complete Response Letter received on December 20, 2022, confirmed that the application review is complete.
2022-12-14	Fresenius Kabi	Regulatory Fresenius Kabi receives FDA approval for biosimilar Idacio® (adalimumab) in the U.S. fresenius.com ↗ The U.S. Food and Drug Administration (FDA) has approved Fresenius Kabi’s biosimilar Idacio®, a citrate-free formulation of adalimumab.
2022-12-14	Fresenius Kabi	Regulatory Fresenius Kabi receives FDA approval for biosimilar Idacio® (adalimumab) in the U.S. fresenius.com ↗ The U.S. Food and Drug Administration (FDA) has approved Fresenius Kabi’s biosimilar Idacio®, a citrate-free formulation of adalimumab.
2022-11-14	Alvotech Swiss AG	Regulatory Alvotech Announces Australian Marketing Authorization for AVT02, a Biosimilar to Humira® alvotech.com ↗ Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide announced today that the Therapeutic Goods Administration of Australia has granted marketing authorization to Cipla Australia Pty Ltd (“Cipla”) for Alvotech’s AVT02, a high-concentration low-volume biosimilar to Humira® (adalimumab).
2022-11-10	UCB Pharma	Results Bimekizumab Demonstrated Sustained Clinical Responses to Week 52 in Phase 3 Studies in Psoriatic Arthritis, Non-Radiographic Axial Spondyloarthritis and Ankylosing Spondylitis ucb.com ↗ At week 52, 54.5 percent of patients continuously treated with bimekizumab, 53.0 percent of patients who switched from placebo to bimekizumab at week 16, and 50.0 percent of patients in the reference arm (adalimumab) achieved ACR50.
2022-10-25	The Medicines Company	Regulatory Novartis maintient sa dynamique de croissance et confirme les prévisions de l’exercice 2022 pour le Groupe novartis.com ↗ La FDA a accepté de revoir la demande de licence supplémentaire d’un biologique (sBLA) pour la formulation à forte concentration du Hyrimoz (adalimumab-adaz).
2022-10-25	Novartis Pharmaceuticals	Regulatory Novartis maintains growth momentum and confirms FY’22 Group guidance novartis.com ↗ FDA accepted for review sBLA for high concentration formulation of biosimilar Hyrimoz (adalimumab-adaz).
2022-09-05	Alvotech Swiss AG	Regulatory Alvotech Reports Update on Initial AVT02 Biologics License Application alvotech.com ↗ The FDA’s Complete Response Letter to the initial biosimilar Biologics License Application (BLA) for AVT02 noted certain deficiencies related to the Reykjavik facility and stated that satisfactory resolution of the deficiencies is required before FDA may approve this BLA.
2022-08-18	Samsung Bioepis Co., Ltd.	Regulatory 삼성바이오에피스, 고농도 휴미라 바이오시밀러(SB5) 미국 허가 samsungbioepis.com ↗ 삼성바이오에피스(대표이사 고한승 사장)는 15일(현지시간) 미국 식품의약국(FDA: Food and Drug Administration)으로부터 휴미라1)(Humira®) 바이오시밀러 하드리마(HadlimaTM)*의 고농도 제형(100 mg/mL) 허가를 획득했다고 밝혔다.
2022-08-17	Organon and Co	Regulatory Samsung Bioepis and Organon Announce FDA Approval of Citrate-Free High-Concentration HUMIRA® Biosimilar HADLIMA™ (adalimumab-bwwd) organon.com ↗ Samsung Bioepis Co., Ltd. and Organon & Co. (NYSE: OGN) today announced the U.S. Food and Drug Administration (FDA) has approved the citrate-free, high-concentration (100 mg/mL) formulation of HADLIMA™ (adalimumab-bwwd), a biosimilar referencing HUMIRA® (adalimumab).
2022-07-21	Sandoz	Regulatory Sandoz Supplemental Biologics License Application accepted by US FDA for biosimilar Hyrimoz® (adalimumab-adaz) high concentration formulation (HCF) sandoz.com ↗
2022-07-21	Novartis Pharmaceuticals	Regulatory Sandoz Supplemental Biologics License Application accepted by US FDA for biosimilar Hyrimoz® (adalimumab-adaz) high concentration formulation (HCF) novartis.com ↗ Sandoz, a global leader in generic and biosimilar medicines, today announced that the US Food and Drug Administration (FDA) has accepted for review its Supplemental Biologics License Application (sBLA) for a high concentration formulation of 100 mg/mL (HCF) of its biosimilar Hyrimoz ® (adalimumab-adaz).
2022-06-17	Sandoz	Regulatory Sandoz Application for proposed biosimilar adalimumab’s high concentration formulation accepted by EMA sandoz.com ↗ Sandoz, a global leader in generic and biosimilar medicines, today announced that the European Medicines Agency (EMA) has accepted the application for high concentration formulation 100 mg/mL (HCF) of its biosimilar Hyrimoz® (adalimumab) for regulatory review.
2022-06-17	Novartis Pharmaceuticals	Regulatory Sandoz Application for proposed biosimilar adalimumab’s high concentration formulation accepted by EMA novartis.com ↗ Sandoz, a global leader in generic and biosimilar medicines, today announced that the European Medicines Agency (EMA) has accepted the application for high concentration formulation 100 mg/mL (HCF) of its biosimilar Hyrimoz ® (adalimumab) for regulatory review.
2022-06-01	Innovent Biologics (Suzhou) Co. Ltd.	Regulatory Innovent Announces the China NMPA Approvals for SULINNO® (adalimumab injection) for the Treatment of Adult and Pediatric Crohn's Diseases innoventbio.com ↗
2022-05-23	UCB Pharma	Results UCB Announces First Detailed Data from Two Phase 3 Bimekizumab Studies in Psoriatic Arthritis to be Presented at EULAR 2022 ucb.com ↗ At week 16, 45.7 percent (n=64/140), 41.2 percent (n=28/68) and 45.0 percent (n=63/140) of patients treated with adalimumab achieved ACR50, PASI90 and MDA, respectively.
2022-03-25	Janssen Research & Development, LLC	Results New Data Show Majority of Adults with Moderate to Severe Plaque Psoriasis Treated with First-in-Class TREMFYA® (guselkumab) Experienced Durable Skin Clearance Through Five Years Regardless of Metabolic Syndrome Status, Baseline Disease Severity, or Treatment History jnj.com ↗ At week 16, patients receiving TREMFYA or adalimumab achieved greater improvements in SRD and SD than those receiving placebo.8
2022-02-28	Alvotech Swiss AG	Regulatory FDA Accepts Alvotech’s BLA Supporting Interchangeability for ATV02, a High Concentration, Citrate-Free Biosimilar Candidate for Humira® alvotech.com ↗
2022-01-10	Alvotech Swiss AG	Regulatory JAMP and Alvotech Announce Canadian Approval of SIMLANDI™, a High-Concentration Biosimilar to Humira®, Providing Access to Previously Unavailable Versions in Canada alvotech.com ↗ JAMP has accordingly been issued notices of compliance for these presentations of SIMLANDI and can launch them in Canada.
2022-01-05	Organon and Co	Regulatory FDA Accepts Samsung Bioepis’ and Organon’s sBLA for their Citrate-Free, High-Concentration HUMIRA® (Adalimumab) Biosimilar Candidate organon.com ↗ the U.S. Food and Drug Administration (FDA) has accepted for review the supplemental Biologics License Application (sBLA) for a citrate-free, high-concentration (100 mg/mL) formulation of SB5 (adalimumab-bwwd), a biosimilar candidate referencing HUMIRA® (adalimumab).
2021-12-28	Shanghai Henlius Biotech	Results Phase 3 clinical results of adalimumab biosimilar 汉达远® in psoriasis patients, published in an international journal Advances in Therapy henlius.com ↗ The results showed that 汉达远® was highly similar to the reference adalimumab in terms of efficacy, safety and immunogenicity.
2021-12-20	Coherus Oncology, Inc.	Regulatory Coherus Announces U.S. FDA Approval of YUSIMRY™ (adalimumab-aqvh) coherus.com ↗ Coherus BioSciences, Inc. (Nasdaq: “CHRS”, “the Company”, “Coherus”) announced that the United States Food and Drug Administration (“FDA”) approved YUSIMRY™ (adalimumab-aqvh), formerly CHS-1420, a Humira® (adalimumab) biosimilar product.
2021-12-16	Alvotech Swiss AG	Regulatory AVT02 Approved for Use in European Union alvotech.com ↗ Alvotech received approval for AVT02 (100 mg/mL), the company’s high concentration biosimilar to Humira® (adalimumab), from the European Commission (EC) on Nov. 15.
2021-10-15	Boehringer Ingelheim	Regulatory U.S. FDA Approves Cyltezo® (adalimumab-adbm) as First Interchangeable Biosimilar with Humira® prnewswire.com ↗ Boehringer Ingelheim today announced the U.S. Food and Drug Administration (FDA) approved the supplemental Biologics License Application (sBLA) for Cyltezo ® (adalimumab-adbm) as the first Interchangeable biosimilar with Humira ® (adalimumab).
2021-10-02	AbbVie	Results AbbVie to Showcase New Data at the United European Gastroenterology (UEG) Week Virtual 2021 abbvie.com ↗ A higher induction dosing regimen of adalimumab does not enhance modulation of downstream blood molecular markers in patients with moderately to severely active Crohn's disease or ulcerative colitis: results from the SERENE-CD and SERENE-UC studies
2021-09-27	Eisai Inc.	Regulatory Fully Human Anti-TNFα Monoclonal Antibody HUMIRA® Obtains Additional Approval for High-Dose Regimen of Ulcerative Colitis in Adult Patients and for New Regimen in Pediatric Patients eisai.com ↗
2021-09-20	Alvotech Swiss AG	Regulatory Alvotech Provides Update on FDA Action Regarding AVT02, Proposed High-Concentration Biosimilar to Humira® (adalimumab) alvotech.com ↗ the FDA is deferring action on the application for AVT02, the company’s proposed biosimilar to Humira®, until facility assessments can be completed.
2021-09-17	Alvotech Swiss AG	Regulatory Alvotech Welcomes Positive CHMP Opinion for AVT02, a Proposed Biosimilar to Humira® alvotech.com ↗ Alvotech, today welcomed the positive opinion of the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) recommending the approval of Alvotech‘s high-concentration AVT02 (100 mg/mL), a proposed biosimilar to Humira® (adalimumab).
2021-06-02	Celltrion	Results Celltrion Healthcare Presents Positive One-Year Data for the First High-Concentration, Low-Volume and Citrate-Free Biosimilar Adalimumab YuflymaTM celltrion.com ↗ Celltrion Healthcare today presented positive results from the Phase III CT-P17 3.1 trial comparing the efficacy and safety of biosimilar adalimumab, Yuflyma™, with reference adalimumab in patients with active rheumatoid arthritis (RA) at the Annual European Congress of Rheumatology 2021 (EULAR Virtual Congress 2021).
2021-06-02	AbbVie	Results New Long-Term Efficacy and Safety Analyses Evaluating RINVOQ® (upadacitinib) in Patients with Rheumatoid Arthritis to be Presented at EULAR 2021 Virtual Congress abbvie.com ↗ In this study, a higher proportion of patients treated with RINVOQ 15 mg achieved and maintained clinical remission and low disease activity compared to those treated with HUMIRA, through three years.
2021-05-24	Janssen Research & Development, LLC	Results Janssen Presents Results of First Head-to-Head Study of Biologic Therapies in Patients with Moderate to Severe Crohn’s Disease jnj.com ↗ although the primary endpoint of statistical superiority versus adalimumab was not demonstrated.
2021-05-23	Janssen Research & Development, LLC	Results Janssen Presents Results of First Head-to-Head Study of Biologic Therapies in Patients with Moderate to Severe Crohn’s Disease jnj.com ↗ Janssen Presents Results of First Head-to-Head Study of Biologic Therapies in Patients with Moderate to Severe Crohn’s Disease
2021-04-23	Boehringer Ingelheim	Results VOLTAIRE-X phase III data in patients with moderate-to-severe chronic plaque psoriasis support interchangeability application prnewswire.com ↗ "We are proud to present the results from Voltaire-X, a landmark study that supports Boehringer Ingelheim's application for interchangeability between Cyltezo® and Humira®," said Thomas Seck, Senior Vice President, Medicine and Regulatory Affairs at Boehringer Ingelheim.
2021-04-23	Eli Lilly and Company	Results Taltz® Delivers More Cumulative Days with Completely Clear Skin for Adults with Psoriasis Compared to Seven Other Biologics in Novel Network Meta-Analysis lilly.com ↗ Taltz offered patients with psoriasis the greatest number of cumulative days of completely clear skin compared to adalimumab, brodalumab, etanercept, guselkumab, risankizumab, secukinumab and ustekinumab.
2021-04-01	AbbVie	Results New England Journal of Medicine Publishes 24-Week Results from Phase 3 Study Evaluating RINVOQ™ (upadacitinib) in Psoriatic Arthritis abbvie.com ↗ 47 percent of patients achieved resolution of enthesitis in the adalimumab group.
2021-02-24	AbbVie	Regulatory HUMIRA® (adalimumab) Receives FDA Approval to Treat Pediatric Patients Living with Moderately to Severely Active Ulcerative Colitis abbvie.com ↗ AbbVie (NYSE: ABBV) today announced that the U.S. Food and Drug Administration (FDA) approved HUMIRA ® (adalimumab) for the treatment of moderately to severely active ulcerative colitis in pediatric patients 5 years of age and older.
2021-02-17	Coherus Oncology, Inc.	Regulatory Coherus BLA Filing for Adalimumab Biosimilar Candidate Accepted by FDA for Review coherus.com ↗ We are pleased to see the CHS-1420 BLA accepted for review as we continue to execute on our mission to increase patient access to important medicines and deliver substantial savings to the healthcare system,
2021-02-15	Celltrion	Regulatory Celltrion Healthcare receives European Commission (EC) approval for the first high concentration, low-volume and citrate-free biosimilar adalimumab celltrion.com ↗ Celltrion Healthcare today announced that on February 11th, the European Commission (EC) has granted marketing authorisation for Yuflyma™ (CT-P17), an adalimumab biosimilar, across all thirteen intended indications for the treatment of multiple chronic inflammatory diseases.
2020-12-23	Innovent Biologics (Suzhou) Co. Ltd.	Regulatory Innovent Announces NMPA Granted New Indication Approvals for SULINNO® (Adalimumab Injection) for the Treatment of Pediatric Plaque Psoriasis and Non-infectious Uveitis innoventbio.com ↗ These are the fifth and sixth approved indications of SULINNO® in China.
2020-12-11	Celltrion	Regulatory Celltrion Healthcare receives EU CHMP positive opinion for biosimilar adalimumab, CT-P17 celltrion.com ↗ The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion of CT-P17 (adalimumab biosimilar) for the treatment of multiple chronic inflammatory diseases
2020-11-27	Eisai Inc.	Regulatory AbbVie and Eisai Announce an approval for additional indication of HUMIRA®, a fully Human Anti-TNFα Monoclonal Antibody, for the treatment of pyoderma gangrenosum for the first time in the world eisai.com ↗ This indication counts for HUMIRA’s 12th indication in Japan and makes HUMIRA the world’s first drug indicated for the treatment of PG.
2020-11-23	Innovent Biologics (Suzhou) Co. Ltd.	Regulatory Innovent Announces NMPA Granted New Indication Approval for SULINNO® (Adalimumab Injection) in China for the Treatment of Polyarticular Juvenile Idiopathic Arthritis innoventbio.com ↗
2020-11-19	Alvotech Swiss AG	Regulatory U.S. FDA and EMA have Accepted Regulatory Submissions for AVT02 - Alvotech alvotech.com ↗ Alvotech today announced that its U.S. subsidiary Alvotech USA Inc. has filed a Biologics License Application (BLA) for AVT02 to the U.S. Food and Drug Administration (FDA), which has been accepted for review.
2020-11-03	Celltrion	Results Celltrion Healthcare Presents Positive Top-Line Efficacy and Safety Results for CT-P17 in the Treatment of Rheumatoid Arthritis celltrion.com ↗ Results demonstrated CT-P17 has equivalent efficacy to reference adalimumab - the ACR20 response rate at week 24 was 82.7% (268/324) for both CT-P17 and reference adalimumab.
2020-10-29	Eli Lilly and Company	Results New Data at EADV 2020 Confirm Taltz® (ixekizumab) Demonstrates Sustained Long-Term Efficacy in Patients with Psoriasis and Psoriatic Arthritis lilly.com ↗ 72% of patients treated with adalimumab (marketed as Humira®).
2020-09-03	Innovent Biologics (Suzhou) Co. Ltd.	Regulatory Innovent Announces NMPA Granted Marketing Approval for SULINNO® (Adalimumab Injection) in China innoventbio.com ↗ SULINNO® is Innovent’s third monoclonal antibody drug approved by the NMPA following TYVYT® (sintilimab injection) and BYVASDA® (bevacizumab injection).
2020-06-04	AbbVie	Results New Long-term Data from RINVOQ™ (upadacitinib, 15 mg) Phase 3 Studies in Rheumatoid Arthritis Presented at 2020 Annual European E-Congress of Rheumatology (EULAR) abbvie.com ↗ Results of this Long-Term Extension (LTE) of the SELECT-COMPARE study show that RINVOQ plus MTX maintained higher levels of clinical response, including remission compared to adalimumab plus MTX, through week 72.
2020-06-03	Bristol-Myers Squibb	Results New Data Reinforce Improved and Durable Clinical Responses of Orencia in Moderate-to-Severe Early Rheumatoid Arthritis Patients with Autoantibodies Linked to More Severe Disease bms.com ↗
2020-06-03	Eli Lilly and Company	Results EULAR 2020: Lilly's Taltz® (ixekizumab) Continues to Show Robust and Consistent Efficacy in Psoriatic Arthritis lilly.com ↗
2020-05-29	Eisai Inc.	Regulatory AbbVie and Eisai Announce an approval for partial changes in the marketing approval of HUMIRA®, a Fully Human Anti-TNFα Monoclonal Antibody, concerning the dosage and administration related to the indication of hidradenitis suppurativa eisai.com ↗ Today, a 80mg Q2W regimen has been newly added as a treatment option with efficacy and safety equivalence to those of the 40mg QW regimen.
2020-05-12	Alvotech Swiss AG	Results Alvotech Announces Positive Top-line Results for Two Comparative Studies. alvotech.com ↗ Alvotech today announce that two studies for AVT02 have met their primary objectives.
2019-11-18	Pfizer	Regulatory FDA Approves Pfizer’s Biosimilar, ABRILADA™ (adalimumab-afzb) for Multiple Inflammatory Conditions pfizer.com ↗ Pfizer Inc. (NYSE: PFE) today announced the United States (U.S.) Food and Drug Administration (FDA) has approved ABRILADA™ (adalimumab-afzb), as a biosimilar to Humira ® (adalimumab), 1 for the treatment of certain patients with rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, adult Crohn's disease, ulcerative colitis and plaque psoriasis.
2019-11-12	Eli Lilly and Company	Results ACR 2019: Lilly Presents 52-Week Head-to-Head (SPIRIT-H2H) Data from Taltz® (ixekizumab) Versus Humira® (adalimumab) Trial in Psoriatic Arthritis lilly.com ↗ At Week 52, 39 percent of patients treated with Taltz had sustained simultaneous joint and skin improvement (ACR50 and PASI 100), compared with 26 percent of patients treated with Humira.
2019-11-01	Novartis Pharmaceuticals	Results Novartis Cosentyx® shows encouraging results versus Humira®* from first-of-its-kind head-to-head trial in psoriatic arthritis novartis.com ↗ Novartis, a leader in rheumatology and immuno-dermatology, today announced results from the EXCEED head-to-head trial comparing Cosentyx ® (secukinumab) to Humira ® * (adalimumab) in patients with active psoriatic arthritis (PsA)[1].
2019-10-22	Samsung Bioepis Co., Ltd.	Results 삼성바이오에피스, 유럽 학회에서 환자 처방 데이터 발표 samsungbioepis.com ↗ 이에 따르면, 오리지널 의약품(휴미라)에서 임랄디로 전환 처방(switching)된 염증성 장질환 환자들의 전환 처방 전∙후 혈청 약물농도가 유사함이 나타났으며, 임랄디로 전환한 후에도 증상 활동지수(activity index)의 염증 부위 표식(marker)에 차이가 없었다.8)
2019-10-21	Takeda	Results Retrospective Real-World Comparative Analysis Highlights Safety of Vedolizumab and Anti-TNFα Therapies in Biologic-Naïve Patients with Ulcerative Colitis or Crohn’s Disease takeda.com ↗ The incidence rates for the first occurrence of a serious adverse event (vedolizumab: 4.6 [3.5-6.8]; anti-TNFα: 10.3 [9.5-14.9]) and serious infections (vedolizumab: 1.4 [0.8-2.5]; anti-TNFα: 2.6 [1.7-4.3]) were estimated to be lower with vedolizumab treatment.
2019-09-25	Takeda	Results First Head-to-Head Biologic Study in Ulcerative Colitis Published in The New England Journal of Medicine Highlights Benefit of Vedolizumab vs. Adalimumab takeda.com ↗ Clinical remission rates at week 52 were superior with vedolizumab at 31.3% (n=120/383) versus 22.5% (n=87/386) with adalimumab (p=0.006).
2019-07-24	Samsung Bioepis Co., Ltd.	Regulatory 삼성바이오에피스, 미국에서 네 번째 제품 판매 허가 획득 samsungbioepis.com ↗ 삼성바이오에피스는 지난 23일(현지시간) 미국 식품의약국(FDA, Food And Drug Administration)으로부터 휴미라 바이오시밀러‘하드리마′ (Hadlima, 성분명: 아달리무맙, 프로젝트명: SB5)의 판매 허가를 최종 통보 받았다고 밝혔다.
2019-06-17	Shanghai Henlius Biotech	Results Henlius Presented Data of Two Anti-inflammatory Candidates at EULAR 2019 henlius.com ↗ In addition to the HLX01, HLX03-HV01 phase 1 study, which demonstrates that HLX03, its adalimumab biosimilar candidate, is bioequivalent to the subcutaneous injection of the China-sourced Humira®.
2019-06-16	Samsung Bioepis Co., Ltd.	Regulatory 삼성바이오에피스, 임랄디 업그레이드로 경쟁력 강화 samsungbioepis.com ↗ 삼성바이오에피스는 최근 유럽 식품의약국(EMA)으로부터 임랄디의 상온 보존가능 기간 (room temperature conditions)을 기존 14일에서 28일로 확대하는 내용의 제품 라벨(product label) 변경 건을 승인받았다.
2019-06-14	Novartis Pharmaceuticals	Results New Sandoz biosimilar adalimumab data confirms switching from reference biologic has no impact on safety or efficacy novartis.com ↗ The 48-week study successfully met its primary and secondary endpoints showing sustained efficacy benefits in patients switched from reference adalimumab to Hyrimoz at Week 24.
2019-06-14	Eli Lilly and Company	Results Lilly Presents Positive Results for Taltz® (ixekizumab) vs. Humira® (adalimumab) in a Head-to-Head (SPIRIT-H2H) Superiority Study in Patients with Active Psoriatic Arthritis at the European Congress of Rheumatology lilly.com ↗ Eli Lilly and Company (NYSE: LLY) announced today that the company will present positive findings from the Phase 3b/4 SPIRIT-Head-to-Head (H2H) study in patients with active psoriatic arthritis (PsA) as a late-breaking abstract at the European Congress of Rheumatology (EULAR) in Madrid, Spain on June 15.
2019-06-13	Samsung Bioepis Co., Ltd.	Results 삼성바이오에피스, 유럽 학회에서 바이오시밀러 입지 강화 samsungbioepis.com ↗ 그리고 총 1,461명의 에타너셉트, 인플릭시맙, 아달리무맙 처방 환자들을 대상으로 한 통합 분석연구(pooled anaysis)에 따르면, 처방 후 6개월및 1년간의 치료 경과를 비교 연구한 결과 삼성바이오에피스의 바이오시밀러 제품군과 오리지널 제품군 간 질환 변동 수준(disease fluctuation)이 유사한 것으로 확인됐다.4)
2019-06-13	Bristol-Myers Squibb	Results New Mechanistic Study Explores the Relationship Between a Key Genetic Marker and Clinical Efficacy of ORENCIA® (abatacept) or adalimumab in Moderate-to-Severe Early Rheumatoid Arthritis Patients bms.com ↗ ACR 20/50/70 responses with ORENCIA were 83, 70 and 48 respectively; ACR 20/50/70 scores for adalimumab were 63, 45 and 30, respectively.
2019-05-19	Takeda	Results New Exploratory Data from VARSITY, the First Head-to-Head Ulcerative Colitis Biologic Study Which Demonstrated Superiority of Vedolizumab to Adalimumab in Clinical Remission at Week 52, Presented at 2019 Digestive Disease Week ® takeda.com ↗ New exploratory data showed that a greater proportion of patients receiving vedolizumab intravenous (IV) achieved clinical response** at week 14 compared to those treated with adalimumab subcutaneous (SC), 67.1% vs. 45.9% respectively.
2019-04-03	Fresenius Kabi	Regulatory Fresenius Kabi receives European Commission approval for adalimumab biosimilar IDACIO® fresenius.com ↗ The European Commission (EC) granted Fresenius Kabi the marketing authorization for IDACIO®, an adalimumab biosimilar, for all indications of the reference medicine.
2019-03-09	Takeda	Results Vedolizumab (Entyvio ® ) Achieves Superior Rates of Clinical Remission vs. Adalimumab (Humira ® ) in First Ever Head-to-Head Biologic Clinical Study in Ulcerative Colitis takeda.com ↗ Vedolizumab superior to adalimumab in achieving clinical remission and mucosal healing at week 52 in patients with moderately to severely active ulcerative colitis
2019-02-21	Eisai Inc.	Regulatory AbbVie and Eisai Announce Fully Human Anti-TNF-α Monoclonal Antibody HUMIRA® is the First in Japan to be Approved for the Treatment of Hidradenitis Suppurativa eisai.com ↗
2019-01-24	Shanghai Henlius Biotech	Regulatory Henlius Adalimumab Received Acceptance of New Drug Application henlius.com ↗ Henlius has recently received a New Drug Application (NDA) acceptance from the National Medical Products Administration (NMPA) for its adalimumab HLX03, a recombinant anti-TNF-α human monoclonal antibody injection.
2018-12-17	Eli Lilly and Company	Results Lilly Announces Positive Top-Line Results for Taltz® (ixekizumab) vs. Humira® (adalimumab) in a Head-to-Head (SPIRIT-H2H) Superiority Study in Patients with Active Psoriatic Arthritis lilly.com ↗ These results provide evidence that Taltz can be used as a first-line biologic treatment for patients with active psoriatic arthritis.
2018-11-13	Innovent Biologics (Suzhou) Co. Ltd.	Regulatory NMPA Accepts Biosimilar New Drug Application for IBI303, a Biosimilar Candidate to Humira® (adalimumab) innoventbio.com ↗
2018-10-31	Novartis Pharmaceuticals	Regulatory Sandoz receives US FDA approval for biosimilar Hyrimoz(TM) (adalimumab-adaz) novartis.com ↗
2018-09-20	Kyowa Kirin, Inc.	Regulatory Mylan and Fujifilm Kyowa Kirin Biologics Receive European Marketing Authorization for Hulio®, Biosimilar Adalimumab kyowakirin.com ↗ MylanN.V. (NASDAQ: MYL) and Fujifilm Kyowa Kirin Biologics Co., Ltd. today announced that the European Commission (EC) has granted marketing authorization for Hulio® (Product Code:FKB327), a biosimilar to AbbVie's Humira® (adalimumab), for all indications.
2018-09-13	AbbVie	Results AbbVie Announces Patient-Reported Outcomes Data from Three Pivotal Phase 3 Studies of Risankizumab, Showing Significant Improvements in Health-Related Quality of Life for Patients with Psoriasis abbvie.com ↗ In IMMvent, significantly more patients treated with risankizumab achieved a Dermatology Life Quality Index (DLQI) score of 0 or 1, indicating psoriasis no longer had impact on their life quality, compared to HUMIRA ® (adalimumab) at week 16.
2018-09-12	Boehringer Ingelheim	Results Biosimilar Cyltezo® demonstrates clinical equivalence to Humira® in patients with moderate-to-severe plaque psoriasis prnewswire.com ↗ Boehringer Ingelheim today announced results from a phase III study, confirming that Cyltezo ® is equivalent to Humira ®* , with no clinically meaningful differences in efficacy, safety and immunogenicity in people with moderate-to-severe chronic plaque psoriasis.
2018-07-27	Novartis Pharmaceuticals	Regulatory Sandoz receives European Commission approval for biosimilar Hyrimoz® (adalimumab) novartis.com ↗ Sandoz, a Novartis division and the pioneer and global leader in biosimilars, today announced that the European Commission (EC) granted marketing authorization to biosimilar Hyrimoz ® (adalimumab) for use in all indications of the reference medicine ** *,
2018-07-27	Kyowa Kirin, Inc.	Regulatory Mylan and Fujifilm Kyowa Kirin Biologics Announce Positive CHMP Opinion for Hulio™, Biosimilar Adalimumab kyowakirin.com ↗ CHMP's decision to recommend the approval of Hulio, a biosimilar to adalimumab, represents a positive step to bring this treatment to patients and demonstrates the strength of our collaboration with Fujifilm Kyowa Kirin Biologics.
2018-06-13	Bristol-Myers Squibb	Results Bristol-Myers Squibb to Present New Research Findings on the Treatment of Patients with Early Rheumatoid Arthritis at the Annual European Congress of Rheumatology (EULAR 2018) bms.com ↗ Analysis comparing abatacept with adalimumab on measures of sustained remission [DAS28 (CRP) < 2.6] and showing seropositive patients with early, erosive RA may respond differently to targeted biologic therapy.
2018-06-01	Novartis Pharmaceuticals	Regulatory Sandoz receives positive CHMP opinion for proposed biosimilar adalimumab novartis.com ↗ Sandoz, a Novartis division and the global leader in biosimilars, today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for marketing authorization of a proposed biosimilar adalimumab.
2018-03-23	Eisai Inc.	Regulatory AbbVie and Eisai Obtain Additional Approval for New Indication of Fully Human Anti-TNF-α Monoclonal Antibody HUMIRA® in the Treatment of Patients who have had an Inadequate Response to Conventional Therapy for Pustular Psoriasis eisai.com ↗ AbbVie GK (Headquarters: Tokyo, President: James Feliciano, “AbbVie”) and Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") today announced the additional approval for a new indication of HUMIRA® (generic name: adalimumab [recombinant], “HUMIRA”), a fully human anti-TNF-α monoclonal antibody formulation, in the treatment of patients who have had an inadequate response to conventional therapy for pustular psoriasis.
2018-02-17	Celltrion	Results CT-P13 (biosimilar infliximab) is comparable to reference infliximab and adalimumab in highly anticipated real-world UK-wide study celltrion.com ↗ The results indicate that the safety and clinical effectiveness, safety and immunogenicity of Celltrion Healthcare’s CT-P13 (biosimilar infliximab) in patients with Crohn’s disease (CD) is comparable to those treated with reference infliximab as well as those treated with adalimumab.
2018-01-16	Novartis Pharmaceuticals	Regulatory Sandoz regulatory submission for proposed biosimilar adalimumab accepted by FDA novartis.com ↗ The FDA's acceptance of the regulatory submission for our biosimilar adalimumab brings us one step closer to offering a portfolio of options to the millions of patients in the US who suffer from an inflammatory disease.
2017-12-18	Fresenius Kabi	Regulatory Fresenius submits first biosimilar Marketing Authorization Application fresenius.com ↗ Fresenius Kabi has submitted a Marketing Authorization Application to the European Medicines Agency for its adalimumab biosimilar candidate of Humira®.
2017-11-14	Novartis Pharmaceuticals	Results New data reinforces clinical basis for switching to Sandoz biosimilar medicines novartis.com ↗ Efficacy and safety of biosimilar adalimumab and safety of biosimilar rituximab match reference medicines in multiple-switching and retreatment study respectively
2017-11-06	Boehringer Ingelheim	Results Efficacy and safety maintained in patients who switched from Humira® to biosimilar Cyltezo® prnewswire.com ↗ The 48-week data showed that Cyltezo is equivalent, with no clinically meaningful differences in efficacy, safety and immunogenicity to Humira in people with moderately-to-severely active rheumatoid arthritis (RA), including in patients who switched from Humira to Cyltezo at week 24.
2017-11-05	Eli Lilly and Company	Results ACR/ARHP 2017: New Analysis Shows Rheumatoid Arthritis Patients Treated with Baricitinib Reported Greater Improvements in Pain Compared to Adalimumab or Placebo lilly.com ↗ Eli Lilly and Company (NYSE: LLY) and Incyte Corporation (NASDAQ: INCY) announced today that patients with moderate-to-severe rheumatoid arthritis (RA) treated with baricitinib reported greater improvements in pain control when compared to Humira®* (adalimumab) or placebo.
2017-11-05	Incyte Corporation	Results ACR/ARHP 2017: New Analysis Shows Rheumatoid Arthritis Patients Treated with Baricitinib Reported Greater Improvements in Pain Compared to Adalimumab or Placebo incyte.com ↗ Eli Lilly and Company (NYSE: LLY) and Incyte Corporation (NASDAQ: INCY) announced today that patients with moderate-to-severe rheumatoid arthritis (RA) treated with baricitinib reported greater improvements in pain control when compared to Humira®* (adalimumab) or placebo.
2017-10-26	AbbVie	Results Risankizumab Meets All Co-Primary and Ranked Secondary Endpoints, Achieving Significantly Greater Efficacy Versus Standard Biologic Therapies in Three Pivotal Phase 3 Psoriasis Studies abbvie.com ↗ today announced positive top-line results from three pivotal Phase 3 clinical trials evaluating risankizumab, an investigational interleukin-23 (IL-23) inhibitor, compared to ustekinumab and adalimumab for the treatment of patients with moderate to severe chronic plaque psoriasis.
2017-09-14	Novartis Pharmaceuticals	Results Sandoz proposed biosimilar adalimumab matches reference biologic in terms of efficacy and safety in long-term study novartis.com ↗ Data from a long-term study of patients continuously treated with the proposed biosimilar or the reference medicine show that efficacy and safety profiles of the two medicines match throughout 51 weeks of treatment in patients with moderate-to-severe chronic plaque psoriasis[1].
2017-08-29	Boehringer Ingelheim	Regulatory Boehringer Ingelheim Pharmaceuticals, Inc. receives FDA approval for Cyltezo™ (adalimumab-adbm), a biosimilar to Humira®, for the treatment of multiple chronic inflammatory diseases prnewswire.com ↗ Boehringer Ingelheim Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration (FDA) approved Cyltezo ™ , a biosimilar to Humira ® , in a pre-filled syringe for the treatment of multiple chronic inflammatory diseases, including:
2017-08-28	Coherus Oncology, Inc.	Results Coherus BioSciences Announces Positive Topline Results for Clinical Pharmacokinetic Bioequivalence Study for CHS-1420 (Humira® Biosimilar Candidate) versus European Marketed Humira in Healthy Subjects coherus.com ↗ The study met the criteria for clinical PK/BE on all prospectively defined endpoints: maximum serum concentration (Cmax), area under the time-concentration curve from first to last time point measured (AUC-0-last), and area under the time-concentration curve from first time point extrapolated to infinity (AUC-0-inf).
2017-08-24	Biogen	Regulatory IMRALDI®, Biogen’s Adalimumab Biosimilar Referencing Humira®, is Approved in the European Union biogen.com ↗ The European Commission (EC) granted a marketing authorization for IMRALDI ® (also known as SB5), an adalimumab biosimilar referencing Humira ® .
2017-08-23	Samsung Bioepis Co., Ltd.	Regulatory 삼성바이오에피스 임랄디(SB5), 유럽 판매 허가 승인 samsungbioepis.com ↗ 삼성바이오에피스는 24일(현지시간), 자가면역질환 치료제(Anti TNF-α)바이오시밀러 ‘임랄디’(Imraldi®, 성분명_ 아달리무맙, 프로젝트名: SB5)가 유럽연합 집행위원회(EC: European Commission)로 부터 최종 판매 허가 승인을 받았다고 발표했다.
2017-07-21	AbbVie	Regulatory AbbVie Receives CHMP Positive Opinion for HUMIRA® (adalimumab) for the Treatment of Pediatric Patients with Chronic Non-infectious Anterior Uveitis abbvie.com ↗ "Today's positive CHMP opinion marks a significant milestone for pediatric uveitis patients and their caregivers," said Marek Honczarenko , vice president, immunology development.
2017-06-24	Samsung Bioepis Co., Ltd.	Regulatory 삼성바이오에피스 임랄디(SB5), 유럽서 긍정 의견 획득 samsungbioepis.com ↗ 삼성바이오에피스는 23일(현지시간), 자가면역질환 치료제(Anti TNF-α) 바이오시밀러인 임랄디가 유럽의약품청(EMA: European Medicines Agency)의 약물사용자문위원회(CHMP: Committee for Medicinal Products for Human Use)로부터 ‘긍정 의견(positive opinion)’을 받았다고 발표 했다.
2017-06-23	Biogen	Regulatory Biogen’s IMRALDI®, an Adalimumab Biosimilar Candidate Referencing Humira®, Granted Positive Opinion by Committee for Medicinal Products for Human Use biogen.com ↗ The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion for IMRALDI ® (also known as SB5), an adalimumab biosimilar candidate referencing Humira ® .
2017-06-16	Pfizer	Results Pfizer Announces Results from XELJANZ® (tofacitinib citrate) ORAL Strategy Study Published in The Lancet and Presented at the EULAR Annual Congress pfizer.com ↗ “As expected, XELJANZ in combination with methotrexate provided similar ACR50 response rates to Humira plus methotrexate,” said Dr. Roy Fleischmann, study author and clinical professor
2017-06-13	AbbVie	Results AbbVie Presents Real-World Data Evaluating the Relationship between Participation in a Patient Support Program and Outcomes in Patients with Moderate to Severe Rheumatoid Arthritis abbvie.com ↗ Results showed that 72.1 percent of patients achieved the MCID in HAQ-DI at week 78 versus baseline (as observed).
2017-05-31	Novartis Pharmaceuticals	Regulatory Sandoz proposed biosimilars adalimumab and infliximab accepted for regulatory review by the European Medicines Agency novartis.com ↗ the European Medicines Agency (EMA) has accepted for regulatory review their Marketing Authorization Applications for biosimilars to AbbVie's Humira ® (adalimumab) and Janssen's Remicade ® (infliximab) both of which are used to treat immunological diseases.
2017-05-22	Kyowa Kirin, Inc.	Regulatory FUJIFILM KYOWA KIRIN BIOLOGICS Announces Marketing Authorisation Application for FKB327 Accepted for Review by European Medicines Agency kyowakirin.com ↗ the European Medicines Agency (EMA) has accepted for review the Marketing Authorisation Application (MAA) for FKB327, an adalimumab biosimilar candidate
2017-03-30	AbbVie	Regulatory U.S. FDA Approves Addition of Moderate to Severe Fingernail Psoriasis Data to AbbVie's HUMIRA® (adalimumab) Prescribing Information abbvie.com ↗ AbbVie (NYSE: ABBV), a global biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) approved the inclusion of moderate to severe fingernail psoriasis data in the HUMIRA® (adalimumab) prescribing information for patients with moderate to severe chronic plaque psoriasis.
2017-03-23	Amgen	Regulatory European Commission Approves AMGEVITA™ (Biosimilar Adalimumab) For The Treatment Of Certain Inflammatory Diseases amgen.com ↗ Amgen (NASDAQ:AMGN) today announced that the European Commission (EC) has granted marketing authorization for AMGEVITA™ (biosimilar adalimumab 1 ) in all available indications.
2017-03-06	Novartis Pharmaceuticals	Results New data demonstrate Sandoz proposed biosimilar adalimumab has equivalent efficacy to reference medicine novartis.com ↗ The Phase 3 confirmatory efficacy, safety and immunogenicity study met its primary endpoint demonstrating GP2017 has equivalent efficacy to the reference medicine, Humira ® [1].
2017-02-16	Pfizer	Results Pfizer Announces Top-Line Results from the Oral Strategy Trial of XELJANZ® (tofacitinib citrate) Compared to Humira® (adalimumab) pfizer.com ↗ XELJANZ 5mg plus MTX met its primary endpoint in demonstrating non-inferiority versus Humira plus MTX
2017-02-15	Eli Lilly and Company	Results Additional results from pivotal RA-BEAM study published in New England Journal of Medicine show baricitinib-treated patients demonstrated sustained improvement in rheumatoid arthritis compared to adalimumab and placebo lilly.com ↗ At week 52, both ACR50 and ACR70 rates were higher in the baricitinib group compared to adalimumab, although only ACR 50 was statistically significant.
2017-02-15	Incyte Corporation	Results Additional results from pivotal RA-BEAM study published in New England Journal of Medicine show baricitinib-treated patients demonstrated sustained improvement in rheumatoid arthritis compared to adalimumab and placebo incyte.com ↗ These improvements were statistically significant compared to adalimumab at weeks 12, 20, 28, 32 and 40.
2017-01-27	Amgen	Regulatory Amgen Receives Positive CHMP Opinion For ABP 501 (Biosimilar Adalimumab) For The Treatment Of Certain Inflammatory Diseases amgen.com ↗ Amgen (NASDAQ:AMGN) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for the Marketing Authorization of ABP 501 (biosimilar adalimumab), recommending approval for all available indications.
2017-01-18	Boehringer Ingelheim	Regulatory Boehringer Ingelheim biosimilar candidate to Humira® accepted for EMA and FDA regulatory review prnewswire.com ↗ Boehringer Ingelheim announced today that BI 695501, its adalimumab biosimilar candidate to Humira ® *, has been accepted for regulatory review by the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA).
2017-01-10	Coherus Oncology, Inc.	Results Coherus BioSciences Announces Positive Topline 24-Week Treatment Phase Three Results for CHS-1420 (HUMIRA® Biosimilar Candidate) in Patients with Psoriasis coherus.com ↗ At the start of Part 2 (Week 16), 80.3% of subjects in the CHS-1420 group and 77.5% of subjects in the HUMIRA group achieved PASI-75.
2017-01-05	Pfizer	Results Pfizer Announces Positive Top-Line Results from the Comparative REFLECTIONS B538-02 Study for PF-06410293, a Potential Biosimilar to Humira®1 (adalimumab) pfizer.com ↗ Pfizer Inc. (NYSE:PFE) today announced that the comparative, confirmatory REFLECTIONS B538-02 study met its primary objective by demonstrating equivalent efficacy as measured by the American College of Rheumatology 20 (ACR20) response rate at Week 12.
2016-11-16	GlaxoSmithKline	Results GSK announces new data from phase III studies of sirukumab in adult patients with moderately to severely active rheumatoid arthritis gsk.com ↗ The second study (SIRROUND-H), a head-to-head study in patients who were refractory to or intolerant to methotrexate (MTX), demonstrated that sirukumab monotherapy met the first of two co-primary endpoints showing significant improvement in disease activity compared to adalimumab monotherapy.
2016-11-14	Novartis Pharmaceuticals	Results Novartis presents new Cosentyx data showing long-lasting efficacy in psoriatic arthritis over 3 years including patient-reported pain novartis.com ↗
2016-11-14	AbbVie	Regulatory AbbVie's HUMIRA® (Adalimumab) Receives CHMP Positive Opinion to Treat Adolescents with Hidradenitis Suppurativa, a Chronic Inflammatory Skin Disease abbvie.com ↗ This positive CHMP opinion is a significant milestone for patients impacted by this painful, chronic disease as there are currently no approved medications available for adolescents to treat it.
2016-10-19	Kyowa Kirin, Inc.	Results Fujifilm Kyowa Kirin Biologics Announces Positive Result in Primary Endpoint from Phase 3 Study of Adalimumab Biosimilar, anti-TNF-α Monoclonal Antibody kyowakirin.com ↗ The primary endpoint (ACR20 response*3), evaluating the disease activity of rheumatoid arthritis after 24 weeks of treatment, met the prespecified criteria of equivalence.
2016-09-28	Eisai Inc.	Regulatory AbbVie and Eisai Obtain Additional Approval for New Indication of Fully Human Anti-TNF-α Monoclonal Antibody HUMIRA® in the Treatment of non-infectious Uveitis The First Biologic Treatment Available for Non-Infectious Intermediate, Posterior and Panuveitis Regardless of Underlying Disease eisai.com ↗ AbbVie GK (Headquarters: Tokyo, President: James Feliciano, “AbbVie”) and Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) today announced the additional approval for a new indication of HUMIRA® (generic name: adalimumab [recombinant], “HUMIRA”), a fully human anti-TNF-α monoclonal antibody formulation, in the treatment of non-infectious intermediate, posterior and panuveitis.
2016-09-26	AbbVie	Results AbbVie Showcases Commitment to Research and Innovation in Dermatology at the 25th European Academy of Dermatology and Venereology Congress abbvie.com ↗ Adalimumab Efficacy in Hidradenitis Suppurativa Patients is Sustained at Least Two Years with Weekly Dosing: Results from a Phase 3 Open-Label Extension Study (PIONEER)
2016-09-23	Amgen	Regulatory FDA Approves Amgen's AMJEVITA™ (Adalimumab-Atto) For Treatment Of Seven Inflammatory Diseases amgen.com ↗ Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration ( FDA ) has approved AMJEVITA™ (adalimumab-atto) across all eligible indications of the reference product, Humira ® (adalimumab).
2016-07-17	Biogen	Regulatory SB5, An Adalimumab Biosimilar Referencing Humira®, Accepted for Review by European Medicines Agency biogen.com ↗
2016-07-12	Amgen	Results Amgen To Discuss Data Supporting Biologics License Application For ABP 501, A Biosimilar Candidate To Adalimumab amgen.com ↗ The Phase 3 studies met their primary endpoints showing clinical comparability to adalimumab.
2016-07-07	AbbVie	Results AbbVie Presents Initial Data from Pivotal Phase-3 Trial Evaluating the Efficacy and Safety of HUMIRA® (adalimumab) for Moderate to Severe Fingernail Psoriasis in Adult Patients at Psoriasis 2016 Congress abbvie.com ↗ 46.6 percent achieved at least a 75 percent improvement in modified Nail Psoriasis Severity Index (mNAPSI) versus 3.4 percent for placebo (p<0.001)
2016-06-30	AbbVie	Regulatory AbbVie's HUMIRA® (adalimumab) Receives U.S. Food and Drug Administration Approval to Treat Adults with Non-Infectious Intermediate, Posterior and Panuveitis abbvie.com ↗ AbbVie (NYSE: ABBV), a global biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has approved HUMIRA® (adalimumab) for the treatment of non-infectious intermediate, posterior and panuveitis.
2016-06-20	Eisai Inc.	Regulatory AbbVie, Eisai, and EA Pharma Obtain Additional Approval for New Dosing Regimen of Fully Human Anti-TNF-α Monoclonal Antibody Humira® in Patients with Crohn's Disease eisai.com ↗ As a result, an additional approval was granted for a change in dosing regimen for these patients.
2016-06-13	Amgen	Regulatory Amgen Announces FDA Advisory Committee Meeting To Review ABP 501, A Biosimilar Candidate To Adalimumab amgen.com ↗ Amgen (NASDAQ:AMGN) today announced that the Arthritis Advisory Committee of the U.S. Food and Drug Administration ( FDA ) will review data supporting the Company's Biologics License Application (BLA) for ABP 501, a biosimilar candidate to Humira ® (adalimumab).
2016-06-09	Biogen	Results New Data Presented at the Annual European Congress of Rheumatology (EULAR 2016) Demonstrate Safety and Efficacy of Biogen’s Anti-TNF Biosimilars Portfolio biogen.com ↗ Results showed sustained and comparable efficacy, and comparable safety and immunogenicity profiles over 52 weeks in patients who transitioned from Humira to SB5 at Week 24, compared with patients who continued to receive the reference product vi and those who continued on SB5.
2016-06-08	Novartis Pharmaceuticals	Results Novartis presents new scientific evidence for Cosentyx in ankylosing spondylitis and psoriatic arthritis patients at EULAR 2016 novartis.com ↗ This includes new long-term analyses suggesting Cosentyx ® (secukinumab) may lead to higher responses than Humira ® * (adalimumab) in improving the signs and symptoms of people living with ankylosing spondylitis (AS) and psoriatic arthritis (PsA) at 52 weeks[3],[4].
2016-05-27	AbbVie	Regulatory AbbVie's HUMIRA® (adalimumab) Receives CHMP Positive Opinion to Treat Certain Forms of Non-Infectious Uveitis, a Disease that Can Severely Impact Vision[1] abbvie.com ↗ Today's CHMP opinion marks a key milestone towards HUMIRA becoming the first approved biologic medication for uveitis, an inflammatory condition of the eye that can impact vision,
2016-04-04	AbbVie	Regulatory AbbVie Receives CHMP Positive Opinion for HUMIRA® (adalimumab) for the Treatment of Pediatric Patients, from Six Years of Age, with Moderately to Severely Active Crohn's Disease abbvie.com ↗ has granted a positive opinion for HUMIRA® (adalimumab)
2016-02-29	Eisai Inc.	Regulatory AbbVie and Eisai Clear All-Case Surveillance Condition for Approval of HUMIRA®, a Fully Human Anti-TNF-α Monoclonal Antibody, in the Treatment of Polyarticular Juvenile Idiopathic Arthritis eisai.com ↗ Japan's Ministry of Health, Labour and Welfare cleared the condition for approval based on a review of an interim report of all-case surveillance on patients with polyarticular juvenile idiopathic arthritis
2016-01-25	Amgen	Regulatory FDA Accepts Amgen's Biosimilar Biologics License Application For ABP 501 amgen.com ↗ Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration ( FDA ) has accepted for review Amgen's Biologics License Application (BLA) for ABP 501, a biosimilar candidate to Humira ® (adalimumab).
2016-01-22	Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd.	Regulatory Shanghai Henlius Obtained the Clinical Approval for the Fifth Monoclonal Antibody Drugs by China Food and Drug Administration (CFDA) fosunpharma.com ↗
2015-12-03	Amgen	Regulatory Amgen's First Biosimilar Marketing Authorization Application Submitted To European Medicines Agency For ABP 501 amgen.com ↗ Amgen (NASDAQ:AMGN) today announced the submission of a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for ABP 501, a biosimilar candidate to Humira ® (adalimumab).
2015-11-25	Amgen	Regulatory Amgen's First Biosimilar Biologics License Application For ABP 501 Submitted To U.S. Food And Drug Administration amgen.com ↗ Amgen (NASDAQ:AMGN) today announced the submission of a Biologics License Application (BLA) with the United States (U.S.) Food and Drug Administration ( FDA ) for ABP 501, a biosimilar candidate to Humira ® (adalimumab).
2015-11-09	Amgen	Results Amgen Presents Detailed Results From Phase 3 Study Demonstrating Clinical Equivalence Of Biosimilar Candidate ABP 501 With Adalimumab amgen.com ↗ Amgen (NASDAQ:AMGN) today presented detailed findings from a head-to-head Phase 3 study comparing the safety, efficacy and immunogenicity of biosimilar candidate ABP 501 with adalimumab in patients with moderate-to-severe rheumatoid arthritis.
2015-11-08	Eli Lilly and Company	Results Detailed Results Demonstrate Baricitinib Superiority to Adalimumab in Improving Signs and Symptoms of Rheumatoid Arthritis lilly.com ↗ At 52 weeks, baricitinib significantly improved all seven components of the ACR composite score compared to adalimumab, including reducing the number of tender and swollen joints, reducing patients' pain and improving physical function.
2015-11-07	Eli Lilly and Company	Results Detailed Results Demonstrate Baricitinib Superiority to Adalimumab in Improving Signs and Symptoms of Rheumatoid Arthritis lilly.com ↗ At 52 weeks, baricitinib significantly improved all seven components of the ACR composite score compared to adalimumab, including reducing the number of tender and swollen joints, reducing patients' pain and improving physical function.
2015-11-07	Incyte Corporation	Results Detailed Results Demonstrate Baricitinib Superiority to Adalimumab in Improving Signs and Symptoms of Rheumatoid Arthritis incyte.com ↗ At 52 weeks, baricitinib significantly improved all seven components of the ACR composite score compared to adalimumab, including reducing the number of tender and swollen joints, reducing patients’ pain and improving physical function.
2015-11-03	AbbVie	Results AbbVie's Leadership and Innovation in Immunology Showcased at the American College of Rheumatology Annual Meeting with More Than 40 Abstracts on HUMIRA® (adalimumab) and Investigational Medicines Across Multiple Inflammatory Diseases abbvie.com ↗ The Majority of Patients with Moderate to Severe Psoriatic Arthritis Had Existing Structural Damage, Predisposing Them to Further Progression, Which Was Markedly Inhibited by Adalimumab
2015-10-14	Eli Lilly and Company	Results Baricitinib Demonstrates Superiority to Adalimumab in Improving Signs and Symptoms of Rheumatoid Arthritis in Pivotal Phase 3 Study lilly.com ↗ Baricitinib was also superior to adalimumab on key secondary objectives of ACR20 response and improvement in DAS28-hsCRP score after 12 weeks of treatment.
2015-09-10	AbbVie	Regulatory AbbVie's HUMIRA® (Adalimumab) Receives First and Only U.S. Food and Drug Administration Approval for Moderate to Severe Hidradenitis Suppurativa abbvie.com ↗ AbbVie (NYSE: ABBV), a global biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) approved HUMIRA ® (adalimumab) for the treatment of moderate to severe hidradenitis suppurativa (HS).
2015-07-30	AbbVie	Regulatory HUMIRA® (Adalimumab) Approved by European Commission for Moderate to Severe Hidradenitis Suppurativa (HS) abbvie.com ↗ AbbVie (NYSE: ABBV), a global biopharmaceutical company, today announced that HUMIRA ® (adalimumab) is approved for the treatment of active moderate to severe hidradenitis suppurativa (acne inversa) in adults with an inadequate response to conventional systemic HS treatment.
2015-06-26	AbbVie	Regulatory AbbVie's HUMIRA® (Adalimumab) Receives Positive CHMP Opinion to Treat Adult Patients with Active Moderate to Severe Hidradenitis Suppurativa, a Chronic Inflammatory Skin Disease abbvie.com ↗ The positive opinion from the CHMP is a significant milestone for people with HS in Europe because it represents progress toward the first and only approved medicine for this devastating disease,
2015-06-10	Biogen	Results Biogen and Samsung Bioepis Announce New Data for Three Anti-TNF Biosimilar Development Candidates at EULAR 2015 Congress biogen.com ↗
2015-06-09	Bristol-Myers Squibb	Results New Post Hoc Analyses of Phase 3b Data Examine Treatment with Orencia (abatacept) Plus Methotrexate (MTX) in Patients with Early Moderate to Severe Rheumatoid Arthritis (RA) and Markers of Poor Prognosis bms.com ↗ Exploratory data of patients with high ACPA levels at baseline in the AMPLE trial suggest better response with Orencia than with adalimumab
2015-06-09	AbbVie	Results AbbVie Presents Phase 3 Data Demonstrating Efficacy and Safety of HUMIRA® (adalimumab) in Children and Adolescents with Severe Chronic Plaque Psoriasis at the 23rd World Congress of Dermatology abbvie.com ↗ AbbVie (NYSE: ABBV) announced new results from a pivotal Phase 3 study of HUMIRA® (adalimumab) demonstrating significant and clinically meaningful efficacy over methotrexate in children and adolescents with severe chronic plaque psoriasis.
2015-05-29	Eisai Inc.	Regulatory AbbVie and Eisai Clear All-Case Surveillance Condition for Approval of HUMIRA®, a Fully Human Anti-TNF-α Monoclonal Antibody, in the Treatment of Ankylosing Spondylitis eisai.com ↗
2015-05-15	AbbVie	Regulatory AbbVie Receives Orphan Drug Designation for HUMIRA® (adalimumab) from the U.S. Food and Drug Administration for the Investigational Treatment of Moderate-to-Severe Hidradenitis Suppurativa (HS) abbvie.com ↗ AbbVie (NYSE: ABBV) announced that the U.S. Food and Drug Administration (FDA) has granted HUMIRA® (adalimumab) orphan drug designation for the investigational treatment of moderate-to-severe hidradenitis suppurativa (HS) ( Hurley Stage II and Hurley Stage III disease), a painful, chronic inflammatory skin disease.
2015-05-05	AbbVie	Results AbbVie Announces Pivotal Phase 3 Data Evaluating Efficacy and Safety of HUMIRA® (adalimumab) in Patients with Non-Infectious Intermediate, Posterior, or Panuveitis abbvie.com ↗ Results showed HUMIRA significantly lowered their risk of uncontrolled uveitis or vision loss.
2015-04-01	AbbVie	Regulatory AbbVie's HUMIRA® (Adalimumab) Approved by European Commission to Treat Children and Adolescents with Severe Chronic Plaque Psoriasis abbvie.com ↗ AbbVie (NYSE: ABBV) announced today that the European Commission (EC) has granted marketing authorization for HUMIRA® (adalimumab) for the treatment of severe chronic plaque psoriasis in children and adolescents from four years of age who have had an inadequate response to or are inappropriate candidates for topical therapy and phototherapies.
2015-02-27	AbbVie	Regulatory AbbVie's HUMIRA® (Adalimumab) Receives Positive CHMP Opinion to Treat Children and Adolescents With Severe Chronic Plaque Psoriasis abbvie.com ↗
2015-02-03	Amgen	Results Amgen Announces Positive Top-Line Results From Phase 3 Study Evaluating The Efficacy And Safety Of Biosimilar Candidate ABP 501 Compared With Adalimumab In Patients With Moderate-To-Severe Rheumatoid Arthritis amgen.com ↗ The ACR20 was within the prespecified margin for ABP 501 compared to adalimumab, showing clinical equivalence.
2014-10-13	AbbVie	Results AbbVie Announces Late-Breaking Results from Phase 3 Trial of HUMIRA® (adalimumab) in Hidradenitis Suppurativa (HS) Patients at the European Academy of Dermatology and Venereology Congress abbvie.com ↗ AbbVie (NYSE: ABBV) announced new results from PIONEER II, a pivotal Phase 3 study, demonstrating the effect of HUMIRA® (adalimumab) in reducing common clinical signs and symptoms in moderate-to-severe hidradenitis suppurativa (HS), specifically the number of abscesses and inflammatory nodules.
2014-10-09	Janssen Research & Development, LLC	Results New Findings From The Psoriasis Longitudinal Assessment And Registry (PSOLAR) jnj.com ↗ This particular analysis of the PSOLAR registry showed higher treatment longevity and lower rates of discontinuation with ustekinumab compared with anti-TNF-alpha agents.
2014-10-06	AbbVie	Regulatory AbbVie's HUMIRA® (adalimumab) Receives U.S. FDA Approval for Extension of Polyarticular Juvenile Idiopathic Arthritis Indication to Patients Ages 2 and Older abbvie.com ↗ AbbVie (NYSE: ABBV) today announced that the U.S. Food and Drug Administration (FDA) has approved the extension of the HUMIRA indication for moderately to severely active polyarticular juvenile idiopathic arthritis (JIA) to reducing signs and symptoms in patients ages 2 and older.
2014-09-25	AbbVie	Regulatory AbbVie's HUMIRA® (adalimumab) Receives U.S. FDA Approval for the Treatment of Pediatric Patients with Moderately to Severely Active Crohn's Disease abbvie.com ↗ AbbVie (NYSE: ABBV) announced today that the U.S. Food and Drug Administration (FDA) has approved HUMIRA ® (adalimumab) for reducing signs and symptoms, and achieving and maintaining clinical remission, in pediatric Crohn's disease patients 6 years of age and older when certain other treatments have not worked well enough.
2014-09-11	AbbVie	Results AbbVie Announces Pivotal Phase 3 Data Evaluating Efficacy of HUMIRA® (adalimumab) in Patients with Hidradenitis Suppurativa (HS), a Chronic Inflammatory Skin Disease abbvie.com ↗ AbbVie (NYSE: ABBV) today announced results from a Phase 3 pivotal study demonstrating that HUMIRA ® (adalimumab) is effective in reducing common clinical signs and symptoms in moderate-to-severe hidradenitis suppurativa (HS), specifically the number of abscesses and inflammatory nodules.
2014-08-14	Coherus Oncology, Inc.	Results Coherus Announces CHS-1420 (Investigational Adalimumab Biosimilar) Meets Primary Endpoint in Pivotal Pharmacokinetic Clinical Study coherus.com ↗ Coherus BioSciences, Inc. (“Coherus”) today announced that CHS-1420, its proposed biosimilar of adalimumab (Humira®), met the primary endpoint in a pivotal clinical pharmacokinetic (PK) similarity study that compared CHS-1420 to Humira® in healthy subjects.
2014-05-20	AbbVie	Regulatory AbbVie Receives Orphan Drug Designation for HUMIRA® (adalimumab) from the U.S. Food and Drug Administration for the Investigational Treatment of Certain Forms of Non-infectious Uveitis abbvie.com ↗
2013-10-03	AbbVie	Results AbbVie Presents Phase II Data Evaluating the Efficacy of HUMIRA® (adalimumab) in Patients with Hidradenitis Suppurativa (HS), a Chronic Inflammatory Skin Disease abbvie.com ↗ The post-hoc analysis found that HUMIRA induced a significant response rate in adult patients with moderate-to-severe HS at week 16 versus placebo (pbo) for the two dosing regimens assessed.
2013-06-14	Eisai Inc.	Regulatory AbbVie and Eisai Announce HUMIRA® Pre-filled Syringe 40 mg / 0.8 mL, a Fully Human Monoclonal Anti-TNF-α Antibody Formulation, Has Received Approval for the Treatment of Moderate to Severe Ulcerative Colitis (UC) in Japan HUMIRA Becomes the First and Only Self-Injectable Biologic Therapy for the Treatment of Moderate to Severe UC eisai.com ↗
2013-06-13	AbbVie	Results AbbVie Presents First Study Assessing the Role of Predefined Doses of Methotrexate When Used in Combination with HUMIRA® (adalimumab) for Rheumatoid Arthritis abbvie.com ↗ CONCERTO shows that at week 26 of treatment, a statistically significant increasing trend was observed in the proportion of patients achieving low disease activity with an increasing dose of MTX when used with open-label HUMIRA®.
2013-06-11	Bristol-Myers Squibb	Results ORENCIA® (abatacept) Shows Comparable Efficacy to Humira® (adalimumab) in Year Two Data from Head-to-Head Study in Patients with Moderate to Severe Rheumatoid Arthritis bms.com ↗ Year 2 data shows similar efficacy between ORENCIA plus methotrexate (MTX) and Humira plus MTX, consistent with the year 1 result which demonstrated comparable efficacy based on a non-inferiority endpoint for ACR 20 response
2013-05-24	Eisai Inc.	Regulatory AbbVie and Eisai Announce HUMIRA® Pre-filled Syringe Has Received Approval for the Treatment of Intestinal Behçet's Disease in Japan HUMIRA is the First Biologic Approved to Treat Intestinal Behçet's Disease in Japan eisai.com ↗
2013-02-15	AbbVie	Results AbbVie Announces First Long-term, Patient-Reported Health Outcomes Data for Use of HUMIRA® (Adalimumab) in Patients with Pediatric Crohn's Disease abbvie.com ↗ For all evaluations, the increase in total IMPACT III scores exceeded 10.8, which has been reported to be indicative of clinically meaningful improvement.
2012-12-13	Rigel Pharmaceuticals	Results AstraZeneca Announces Top-Line Results of OSKIRA-4 Phase IIb Study of Fostamatinib as a Monotherapy for Rheumatoid Arthritis rigel.com ↗ The adalimumab monotherapy ACR20 result at the 24 week endpoint was 59%.
2012-12-13	AstraZeneca	Results AstraZeneca announces top-line results of OSKIRA-4 Phase IIb study of fostamatinib as a monotherapy for rheumatoid arthritis astrazeneca.com ↗ The OSKIRA-4 study did not meet its second primary objective as all fostamatinib monotherapy doses were inferior to adalimumab monotherapy at week 24 based on DAS28.
2012-11-12	Bristol-Myers Squibb	Results New Head-to-Head Patient Reported Outcomes Data for Orencia ® SC (abatacept) vs. Humira® (adalimumab) Presented at the 2012 American College of Rheumatology Annual Scientific Meeting bms.com ↗ At one year, Orencia SC plus MTX was similar to Humira plus MTX in improving patient pain (53.0% and 39.2%), improving patient global assessment (46.1% and 41.2%) and decreasing fatigue (-23.2% and -21.4%).
2012-10-29	Eisai Inc.	Regulatory Abbott Japan and Eisai Clear All-Case Surveillance Condition for Approval of Humira®, a Fully Human Anti-TNF-α Monoclonal Antibody, in the Treatment of Crohn’s Disease eisai.com ↗
2012-08-10	Eisai Inc.	Regulatory Abbott Japan and Eisai Receive Approval to Market the Fully Human Anti-TNF-Alpha Monoclonal Antibody Humira® (adalimumab) For the Inhibition of Structural Damage of Joints in Patients with Rheumatoid Arthritis eisai.com ↗ However, the approval of this latest indication will enable the drug to be administered to patients with rapid progression of structural damage even if they have not received prior treatment with anti-rheumatic drugs.
2012-06-06	Bristol-Myers Squibb	Results ORENCIA® (abatacept) Demonstrates Comparable Efficacy to Humira® (adalimumab) in Patients with Moderate to Severe Rheumatoid Arthritis in First Head-to-Head Study of These Agents bms.com ↗ ORENCIA demonstrated comparable efficacy to Humira based on a non-inferiority endpoint for ACR20 response at 1 year
2012-04-23	Eisai Inc.	Regulatory Abbott Japan and Eisai have Cleared the Condition for Approval of Humira®, a Fully Human Anti-TNF-α Monoclonal Antibody, for Plaque Psoriasis and Psoriasis Arthropica in Terms of the All-Case Surveillance eisai.com ↗
2011-09-26	Eisai Inc.	Regulatory Abbott Japan and Eisai Submit Application in Japan for Additional Indication of Humira® (adalimumab), a Fully Human Anti-TNF-α Monoclonal Antibody, for Inhibition of Structural Damage of Joints in Rheumatoid Arthritis eisai.com ↗
2011-07-01	Eisai Inc.	Regulatory Abbott Japan and Eisai Receive Approval in Japan for Additional Indication and New Formulation of Humira®, a Fully Human Anti-TNF-α Monoclonal Antibody, for the Treatment of Juvenile Idiopathic Arthritis eisai.com ↗ In addition to the new indication, Humira® Pre-filled Syringe 20 mg/0.4 mL for Subcutaneous Injection, a new formulation for patients with a low body weight, also received approval from the MHLW.
2010-10-29	Eisai Inc.	Regulatory Abbott Japan and Eisai Receive Approval for Additional Indications of Humira®, a Fully Human Anti-TNFα Monoclonal Antibody, for the Treatment of Crohn's Disease and Ankylosing Spondylitis eisai.com ↗
2010-10-28	Eisai Inc.	Regulatory Abbott Japan and Eisai have Cleared the Condition for Approval of Humira®, a Fully Human Anti-TNF-alpha Monoclonal Antibody, for Rheumatoid Arthritis in Terms of the All-Case Surveillance eisai.com ↗ The MHLW cleared the condition for approval on the basis of the review of the safety and efficacy of Humira® in 3,084 patients with rheumatoid arthritis who participated in the all-case surveillance.
2010-08-30	Eisai Inc.	Regulatory Abbott Japan and Eisai Submit Application for Additional Indication of Humira®, a Fully Human Anti-TNFα Monoclonal Antibody, for the Treatment of Juvenile Idiopathic Arthritis in Japan eisai.com ↗ In addition to the application for approval of the additional indication, the two companies also submitted an application for approval of Humira® pre-filled syringe 20 mg/0.4 mL for use in JIA patients of low body weight.
2010-01-20	Eisai Inc.	Regulatory Fully Human Monoclonal Anti-TNF-α Antibody HUMIRA® Receives Approval as Japan's First Biological Agent for Psoriasis eisai.com ↗ Abbott Japan Co., Ltd. (Pharmaceutical Products Group Headquarters: Tokyo, President: Gary M. Winer, “Abbott Japan”) and Eisai Co., Ltd. (Headquarters: Tokyo, President and CEO: Haruo Naito, “Eisai”) today announced that HUMIRA® pre-filled syringe 40 mg/0.8 mL for subcutaneous injection (generic name: adalimumab) has received approval for the additional indications of plaque psoriasis (PS) and psoriatic arthritis (PSA).
2009-10-28	Eisai Inc.	Regulatory Abbott Submits Marketing Authorization Application of Humira® (adalimumab), a Fully Human Monoclonal anti-TNF-α Antibody, for the Treatment of Ankylosing Spondylitis in Japan eisai.com ↗ they had submitted an application for approval for the treatment of ankylosing spondylitis as an additional indication for Humira®
2009-09-30	Eisai Inc.	Regulatory Abbott and Eisai Submit Application for Approval of Humira® (Adalimumab), a Fully Human Monoclonal Anti-TNF-α Antibody, for the Treatment of Crohn's Disease in Japan eisai.com ↗ Abbott Japan Co., Ltd. (Pharmaceutical Products Group, Headquarters: Tokyo, President: Glenn S. Warner, “Abbott Japan”) and Eisai Co., Ltd. (Headquarters: Tokyo, President and CEO: Haruo Naito, “Eisai”) announced today that they had submitted an application for approval of Crohn's disease as an additional indication for Humira® (adalimumab), a fully human monoclonal anti-TNF-α antibody jointly developed by the two companies.
2008-04-16	Eisai Inc.	Regulatory HUMIRA® received approval for the treatment of rheumatoid arthritis in Japan eisai.com ↗ HUMIRA® (adalimumab), Abbott's fully-human monoclonal anti-TNF-α antibody that the companies had co-developed, received approval for manufacturing/distribution in Japan for the treatment of rheumatoid arthritis.
2007-09-25	Eisai Inc.	Regulatory Abbott and Eisai submit application for adalimumab, the only fully human monoclonal anti-TNFα antibody, to treat psoriasis eisai.com ↗
2007-07-09	Halozyme Therapeutics	Results Halozyme Therapeutics' Enhanze Technology Large Protein Molecule Therapeutic Clinical Trial Results Presented at the 34th Annual Meeting of the Controlled Release Society halozyme.com ↗ Co-Injection of rHuPH20 with HUMIRA(R) Estimated to Increase the Maximal Steady State Subcutaneous Bioavailability from 64% to 100%

All press releases naming this drug 317 releases

Date	Issuer	Release
Show all 317 releases opens the full record — a long page

Evidence & citations 46 cited values

Every value below carries the sentence it was read from. 515 sources stand behind the page.

Field	Value	Cited text
Known as	Adalimumab	“A total of 216 patients with inflammatory bowel disease from the Inflammatory Unit of the Virgin Macarena University Hospital will be randomized 1:1 to receive the study drug,...” NCT04131322 ↗ 460 “The cohort A (borderline resectable) and cohort B (locally advanced) both received treatment with gemcitabine, albumin paclitaxel (administered on days 1, 8, and 15, with 4...” NCT07208539 ↗ “An international multicentre randomized trial of a humanized monoclonal antibody, adalimumab, in JIA has demonstrated its efficacy on joint lesions and its good safety as...” NCT01385826 ↗ “To be given subcutaneously via a prefilled syringe/autoinjector (etanercept, adalimumab, certolizumab pegol, golimumab) or intravenously via infusion (infliximab) at increasing...” NCT05115903 ↗ “Randomization to: Adalimumab: induction 160/80 mg SC and Maintenance 40 mg EOW SC OR Loss of response under Adalimumab: 40mg EW SC Randomization to: Infliximab: 5mg/kg IV at...” NCT03580876 ↗ “RA treated with subcutaneous TNF-blockers (etanercept or adalimumab) at stable and standard dosage for 1 year or more, as monotherapy or associated with stable conventional DMARD;” NCT00780793 ↗ “TNF-a inhibitors: Etanercept (Enbrel, Benapali), Infliximab (Remicade, Inflectra, Flixabi), Adalimumab (Humira, Imraldi, AMGEVITA), Certolizumabpegol (Cimzia), Golimumab (Simponi)” NCT04378621 ↗ “Adalimumab (Humira; Abbott Laboratories, Abbot Park, IL) is a fully human, monoclonal antibody directed against TNF-α and is approved by the US FDA to treat rheumatoid arthritis.” NCT00731757 ↗ “Adalimumab-adbm (Cyltezo®) is approved by the US Food and Drug Administration as an interchangeable biosimilar to the adalimumab reference product (RP; Humira®).” PMID 40498294 ↗ Jun 2025 “infliximab, and adalimumab are the main TNF inhibitors available for children10 and are used in the treatment of refractory or chronic childhood uveitis 11,12 .” NCT05540743 ↗ “These medicines were reference adalimumab (brand name Humira®) and biosimilar GP2017 (also known as Sandoz-adalimumab and sold under the brand name Hyrimoz®).” PMID 41709696 ↗ Feb 2026 Show 450 more sources
Known as	ABP 501	ClinicalTrials.gov intervention name — accepted as the source's own label NCT01970488 ↗ 4 NCT02114931 ↗ NCT01970475 ↗ NCT05909852 ↗ NCT05073315 ↗
Known as	ABP 501-HCF	“ABP 501 40 mg/0.4 mL (ABP 501-HCF) and ABP 501 40 mg/0.8 mL (ABP 501-LCF)” NCT05909852 ↗
Known as	ABP 501-LCF	“ABP 501 40 mg/0.4 mL (ABP 501-HCF) and ABP 501 40 mg/0.8 mL (ABP 501-LCF)” NCT05909852 ↗
Known as	ADA	“Adalimumab, a fully human anti-tumor necrosis factor α monoclonal antibody, is effective in the treatment of many rheumatic diseases. ADA as the initial treatment in adult...” NCT04588818 ↗ 23 “the influence of symptom duration on treatment response and on the correlation between improvements in patient reported outcomes (PRO) and objective inflammation in patients...” PMID 24476416 ↗ Jan 2014 “The aim of this trial was to assess the possibility of discontinuing treatment with adalimumab (ADA) while maintaining remission in patients with RA with established disease in...” PMID 26819752 ↗ Jan 2016 “The purpose of this study is to determine the safety and efficacy of the use of the combination therapy adalimumab (ADA) every other week (EOW) with methotrexate (MTX) in...” NCT02196701 ↗ “treatment with tofacitinib monotherapy versus tofacitinib or adalimumab (ADA) in combination with methotrexate (MTX) in patients with rheumatoid arthritis (RA) with inadequate...” PMID 31673419 ↗ Oct 2019 “Adalimumab (ADA) is a subcutaneously (SC) self-administered fully human Ig G1 monoclonal antibody directed against tumor necrosis factor alpha (TNFα) which will be used intravitreally.” NCT00855608 ↗ “In the SPIRIT-H2H (ClinicalTrials.gov: NCT03151551) trial in biologic-naïve patients with active psoriatic arthritis (PsA), ixekizumab (IXE) was superior to adalimumab (ADA) at week 24” PMID 33200394 ↗ Nov 2020 “Adalimumab (ADA) was evaluated for its efficacy in patients with moderate to severely active psoriatic arthritis (PsA) and for the presence of correlations in disease change variables.” PMID 25834212 ↗ Apr 2015 “PURPOSES: This study investigated the feasibility of adalimumab (ADA) dose reduction and withdrawal strategy in children with stable pediatric non-infectious uveitis (PNIU).” PMID 38652891 ↗ Apr 2024 “comparing the efficacy, safety and cost-effectiveness of methotrexate (MTX), adalimumab (ADA), or their combination in non-infectious non-anterior uveitis.” NCT04798755 ↗ “Adalimumab (ADA), an anti-TNFα monoclonal antibody, has marketing authorization and is widely used in the treatment of UCNI as a relay to corticosteroids.” NCT06390436 ↗ Show 13 more sources
Known as	Adalimumab+NALIRIFOX→Short course radiotherapy →Adalimumab+NALIRIFOX	ClinicalTrials.gov intervention name — accepted as the source's own label NCT07622771 ↗
Known as	adalimumab, ABT-D2E7, Humira	“adalimumab, ABT-D2E7, Humira” NCT00690573 ↗
Known as	adalimumab-680LT	“fluorescently labeled adalimumab (adalimumab-680LT)” NCT07258641 ↗
Known as	adalimumab-atto	“Adalimumab-atto (AMJEVITA®, USA)/AMGEVITA®, EU; Amgen Inc.), also known as ABP 501, is an approved biosimilar to adalimumab (HUMIRA®, AbbVie Inc.).” PMID 41954860 ↗ Apr 2026
Known as	ADL	“We aimed to assess the effect of adalimumab (ADL) treatment on linear growth in children with CD in a post-hoc analysis of the Pediatric Crohn's Disease AdalImumab Level-based...” PMID 32324651 ↗ Aug 2020 1 “adalimumab (ADL) biosimilar PF-06410293 (ADL-PF: adalimumab-afzb; Abrilada®/Amsparity®/Xilbrilada®)” PMID 35304684 ↗ Mar 2022
Known as	ADL-EU	“reference ADL sourced from the European Union (ADL-EU)” PMID 34563243 ↗ Sep 2021
Known as	ADM	“Here, we aimed to evaluate the feasibility and volunteers' perception of home microsampling for quantification of adalimumab (ADM) concentrations in psoriasis patients.” PMID 35683398 ↗ May 2022
Known as	Advixa	“Incepta Pharmaceuticals Ltd. Bangladesh has introduced Bangladesh's first locally manufactured adalimumab biosimilar Advixa that is available at a fraction of Humira's cost.” NCT05172817 ↗
Known as	AMGEVITA	“Adalimumab-atto (AMJEVITA®, USA)/AMGEVITA®, EU; Amgen Inc.), also known as ABP 501, is an approved biosimilar to adalimumab (HUMIRA®, AbbVie Inc.).” PMID 41954860 ↗ Apr 2026
Known as	AMJEVITA	“Adalimumab-atto (AMJEVITA®, USA)/AMGEVITA®, EU; Amgen Inc.), also known as ABP 501, is an approved biosimilar to adalimumab (HUMIRA®, AbbVie Inc.).” PMID 41954860 ↗ Apr 2026
Known as	AVT02	“who selfinject AVT02 (adalimumab) subcutaneously (SC).” NCT04224194 ↗ 2 “AVT02 100mg/mL (Adalimumab Biosimilar)” NCT03849404 ↗ NCT03579823 ↗
Known as	BCD-057	“Adalimumab (BCD-057) 100 mg/mL” NCT07181694 ↗ 1 NCT02762955 ↗
Known as	CinnoRA	“This study aimed to compare efficacy and safety of test-adalimumab (CinnoRA®, CinnaGen, Iran) to the innovator product (Humira®, AbbVie, USA) in adult patients with active...” PMID 28728599 ↗ Jul 2017
Known as	D2E7	“A Multi-Center Continuation Trial for Patients Completing Study M02-518 and M02-570 of the Human Anti-TNF Monoclonal Antibody Adalimumab (D2E7) in Patients With Moderate to...” NCT00195689 ↗ 6 “A Multi-Centre Randomized, Double-Blind Study Comparing Adalimumab (D2E7) Plus Methotrexate With Placebo Plus Methotrexate on Work Disability in Subjects With Early Rheumatoid Arthritis” NCT00234845 ↗ “A Multi-Center Continuation Study of the Human Anti-TNF Antibody D2E7 Administered as a Subcutaneous Injection in Patients With Rheumatoid Arthritis” NCT00195650 ↗ “the Fully Human Anti-TNF-α Monoclonal Antibody Adalimumab (D2E7) When Added to Inadequate Standard Anti-Rheumatic Therapy” NCT00448383 ↗ “adalimumab (D2E7)” NCT00085644 ↗ “adalimumab (D2E7)” NCT00195819 ↗ “Adalimumab (D2E7)” NCT00055523 ↗
Known as	Drug: Adalimumab (Humira)	“Drug: Adalimumab (Humira)” NCT02456363 ↗
Known as	EU-adalimumab	“European Union-approved adalimumab (EU-adalimumab)” PMID 33503313 ↗ Mar 2021
Known as	EU-Humira	“Participants received EU-Humira subcutaneously in EU-Humira, EU-Humira/EU-Humira and EU-Humira/MSB11022 arm.” NCT02660580 ↗ 1 “EU-Humira 100mg/mL (Adalimumab Originator)” NCT03849404 ↗
Known as	FITC-Adalimumab	“The study product FITC-Adalimumab will be topically applied via a spray catheter to the intestinal mucosa of Crohn's disease patients during endomicroscopy of the gut.” NCT01275508 ↗
Known as	GP-2017	“Sandoz adalimumab SDZ-ADL (GP-2017) is an approved adalimumab biosimilar.” PMID 33119861 ↗ Dec 2020 2 NCT02016105 ↗ NCT03259074 ↗
Known as	Hadlima	“Remicade, Inflectra, Renflexis, Avsola, Humira, Amgevita, Hulio, Hadlima, Hyrimoz, Idacio” NCT05781152 ↗ 1 NCT07849153 ↗
Known as	Hulio	“Remicade, Inflectra, Renflexis, Avsola, Humira, Amgevita, Hulio, Hadlima, Hyrimoz, Idacio” NCT05781152 ↗ 1 NCT05637515 ↗
Known as	Humira	“This study aimed to compare efficacy and safety of test-adalimumab (CinnoRA®, CinnaGen, Iran) to the innovator product (Humira®, AbbVie, USA) in adult patients with active...” PMID 28728599 ↗ Jul 2017 63 “Adalimumab (Humira; Abbott Laboratories, Abbot Park, IL) is a fully human, monoclonal antibody directed against TNF-α and is approved by the US FDA to treat rheumatoid arthritis.” NCT00731757 ↗ “Discontinuation of infusion infliximab (Remicade) 3-5mg/kg every 6-8 week, injection of etanercept (Enbrel) 25 mg x 2/week or injection of adalimumab (Humira) 40 mg eow.” NCT00726804 ↗ “Adalimumab (Humira, AbbVie) is a highly effective treatment for a variety of auto-immune/auto-inflammatory diseases including juvenile idiopathic arthritis (JIA).” NCT03607903 ↗ “The purpose of this study is to assess the effect of adalimumab (Humira), when compared to NB-UVB (narrow-band ultraviolet B) phototherapy or placebo” NCT01553058 ↗ “Evaluation of the Safety and Effectiveness of Switching From Originator (Humira®) to Biosimilar (Imraldi®) Adalimumab in Flanders (SafE-OrBi)” NCT04045782 ↗ “The purpose of this research study is to compare the efficacy and safety of SCT630 and adalimumab (HUMIRA®) in adults with plaque psoriasis.” NCT03927352 ↗ “Each active treatment involves 1 (one) s.c. injection of adalimumab 40 mg/0,8 mL solution for injection for paediatric use (Humira®)” NCT02097264 ↗ “One out of seven will receive adalimumab (Humira®) and one out of seven will only receive inactive substances (placebo.)” NCT00550446 ↗ “a single subcutaneous 0.57 mg/kg dose of adalimumab (Humira®) reference product from North American source” NCT03254810 ↗ “Active Study Drug is Adalimumab (Humira) which is FDA approved to treat rheumatoid arthritis since 2003.” NCT01893996 ↗ Show 53 more sources
Known as	Humira (Adalimumab)	“Humira (Adalimumab)” NCT00853385 ↗ 2 “humira (adalimumab)” NCT00480272 ↗ “Humira (Adalimumab)” NCT01564823 ↗
Known as	HumiraR	“The main objective of this studies therapeutic : to determine the effect of Adalimumab (HumiraR) on clinical inflammatory manifestations of patients with Netherton syndrome...” NCT02113904 ↗
Known as	Hyrimoz	“These medicines were reference adalimumab (brand name Humira®) and biosimilar GP2017 (also known as Sandoz-adalimumab and sold under the brand name Hyrimoz®).” PMID 41709696 ↗ Feb 2026 1 “Remicade, Inflectra, Renflexis, Avsola, Humira, Amgevita, Hulio, Hadlima, Hyrimoz, Idacio” NCT05781152 ↗
Known as	Idacio	“Remicade, Inflectra, Renflexis, Avsola, Humira, Amgevita, Hulio, Hadlima, Hyrimoz, Idacio” NCT05781152 ↗ 1 “Adalimumab(Idacio) 40 mg subcutaneously (sc) every other week” NCT05153200 ↗
Known as	Imraldi	“Evaluation of the Safety and Effectiveness of Switching From Originator (Humira®) to Biosimilar (Imraldi®) Adalimumab in Flanders (SafE-OrBi)” NCT04045782 ↗
Known as	LBAL	ClinicalTrials.gov intervention name — accepted as the source's own label NCT02746380 ↗ 1 NCT02206867 ↗
Known as	ref-ADL	“Both studies evaluated and confirmed equivalent efficacy, similar safety, and immunogenicity of SDZ-ADL with reference adalimumab (ref-ADL).” PMID 33651341 ↗ Mar 2021
Known as	Sandoz-adalimumab	“These medicines were reference adalimumab (brand name Humira®) and biosimilar GP2017 (also known as Sandoz-adalimumab and sold under the brand name Hyrimoz®).” PMID 41709696 ↗ Feb 2026
Known as	SB5	“Usability and safety of SB5 (an adalimumab biosimilar) prefilled syringe and autoinjector in patients with rheumatoid arthritis.” PMID 30561229 ↗ Jan 2019 4 NCT05510063 ↗ NCT02144714 ↗ NCT02326233 ↗ NCT02167139 ↗
Known as	SDZ-ADL	“An adalimumab (tumor necrosis factor [TNF] inhibitor) biosimilar, GP2017 (SDZ-ADL; Sandoz), has been approved by the European Medicines Agency (July 2018) for use in all same...” PMID 31983056 ↗ Mar 2020 1 “SDZ-ADL (GP2017; Sandoz GmbH, Austria) is an EMA-/FDA-approved adalimumab biosimilar.” PMID 33651341 ↗ Mar 2021
Known as	Tabellvi	“Tabellvi® (Adalimumab) in Chinese Adult Subjects With Moderate to Severe Active Crohn's Disease” NCT07663526 ↗
Known as	Taibowei	“A Clinical Trial of Taibowei® Adalimumab Injection in the Treatment of Chinese Pediatric Patients With Moderately to Severely Active Crohn's Disease” NCT07564505 ↗
Known as	Tebiovio	“Efficacy and Safety of Tebiovio® (Adalimumab) in Treating Chinese Children With Severe Plaque Psoriasis” NCT07663331 ↗
Known as	TyboWe	“TyboWe® Adalimumab Injection” NCT07663331 ↗ 1 “TyboWe® Adalimumab Injection” NCT07663526 ↗
Known as	US-adalimumab	“United States-licensed adalimumab (US-adalimumab)” PMID 33503313 ↗ Mar 2021
Action	Inhibit	“adalimumab, a fully human monoclonal anti-TNF antibody” PMID 18716298 ↗ Aug 2008
Modality	Monoclonal antibody	“adalimumab, a fully human monoclonal anti-TNF antibody” PMID 18716298 ↗ Aug 2008
Route	Subcutaneous	“Patients who received ≥1 dose of adalimumab subcutaneously” PMID 30054164 ↗ Jul 2018
Target	TNF	“adalimumab, a fully human monoclonal anti-TNF antibody” PMID 18716298 ↗ Aug 2008