Infliximab

also known as Remicade · IFX · CT-P13 · TA-650 · Inflectra · Remsima · Infliximab-dyyb · Remicade (Registered Trademark) · +18 more

Monoclonal antibody targets TNF via inhibition

Developed for: Crohn disease · rheumatoid arthritis · ulcerative colitis · psoriasis · ankylosing spondylitis · psoriatic arthritis · inflammatory bowel disease · spondyloarthropathy
+89 more
· COVID-19 · Kawasaki disease · Behcet disease · depressive disorder · uveitis · sarcoidosis · Takayasu arteritis · acute graft versus host disease · arthritic joint disease · chronic hepatitis C virus infection · chronic obstructive pulmonary disease · colitis · corneal disorder · graft versus host disease · hidradenitis suppurativa · melanoma · metastatic melanoma · Stevens-Johnson syndrome · vasculitis · acute kidney injury · acute tubulointerstitial nephritis · asthma · atopic eczema · bipolar depression · brain aneurysm · cardiac arrest · chemical colitis · chronic beryllium disease · cytokine release syndrome · dermatomyositis · diabetic macular edema · diabetic retinopathy · dry eye syndrome · eating disorder · endometriosis · esophagitis · glaucoma · granulomatosis with polyangiitis · hypertensive disorder · hypoproteinemia, hypercatabolic · idiopathic scleritis · juvenile idiopathic arthritis · lumbar stenosis, familial · lupus nephritis · macular degeneration · macular retinal edema · major depressive disorder · microscopic polyangiitis · mucous membrane pemphigoid · myelodysplastic syndrome · myositis disease · osteoarthritis, knee · pemphigus · perianal Crohn disease · polyarticular juvenile idiopathic arthritis · polyarticular juvenile rheumatoid arthritis · polymyalgia rheumatica · post-cardiac arrest syndrome · pustular psoriasis · pyoderma gangrenosum · reactive arthritis · relapsing polychondritis · schizophrenia · scleritis · Sjogren syndrome · small bowel Crohn disease · spondylitis · systemic lupus erythematosus · temporal arteritis · toxic epidermal necrolysis · transplant rejection · tropical spastic paraparesis · type 1 diabetes mellitus · acute pancreatitis · age-related macular degeneration · anal fistula · choroidal neovascularization · Cogan syndrome · COVID-19–associated multisystem inflammatory syndrome in children · Cryoglobulinemic vasculitis · cutaneous polyarteritis nodosa · eosinophilic granulomatosis with polyangiitis · immunoglobulin A vasculitis · metabolic syndrome X · obesity disorder · primary central nervous system vasculitis · proliferative vitreoretinopathy · rhegmatogenous retinal detachment · type 2 diabetes mellitus
Investigated by: Centocor, Inc. · Merck Sharp & Dohme LLC · Celltrion · Tanabe Pharma Corporation · Emory University · Schering-Plough
+258 more
· Assistance Publique - Hôpitaux de Paris · Centocor Ortho Biotech Services, L.L.C. · Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives · Massachusetts General Hospital · National Institute of Allergy and Infectious Diseases (NIAID) · National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) · National Institute of Mental Health (NIMH) · Academic Medical Center - University of Amsterdam · Children's Hospital Medical Center, Cincinnati · Erasmus Medical Center · Icahn School of Medicine at Mount Sinai · National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · University of California, San Francisco · World Health Organization · Xian-Janssen Pharmaceutical Ltd. · Asan Medical Center · Charite University, Berlin, Germany · Children's Hospital of Fudan University · Diakonhjemmet Hospital · Fonds de recherche en ophtalmologie de l'Université de Montréal · Helsinki University Central Hospital · Hvidovre University Hospital · Imperial College London · Integrated Therapeutics Group · Janssen Research & Development, LLC · Janssen Scientific Affairs, LLC · Massachusetts Eye and Ear Infirmary · Medical Research Council · Medical University of Graz · Medical University of Vienna · NYU Langone Health · National Cancer Institute (NCI) · Nationwide Children's Hospital · Oregon Health and Science University · Pfizer · Seoul National University Hospital · Services Institute of Medical Sciences, Pakistan · Shanghai 10th People's Hospital · Shanghai Children's Medical Center · Sixth Affiliated Hospital, Sun Yat-sen University · Taizhou Mabtech Pharmaceutical Co.,Ltd · University Health Network, Toronto · University Medical Center Groningen · University of California, San Diego · University of Erlangen-Nürnberg Medical School · University of Leeds · University of Montreal Hospital Centre (CHUM) · University of Roma La Sapienza · AESCA Pharma GmbH · Aalborg University Hospital · AbbVie · All India Institute of Medical Sciences · Alliance for Clinical Trials in Oncology · American Cancer Society, Inc. · Apotex Inc. · Arch Biopartners Inc. · Asian Institute of Gastroenterology, India · Association de Recherche Clinique en Rhumatologie · Autoimmunity Centers of Excellence · Belgian Inflammatory Bowel Disease Research and Development (BIRD) VZW · Beth Israel Deaconess Medical Center · Biocad · Bnai Zion Medical Center · Bristol-Myers Squibb · Bühlmann Laboratories AG · CMC Ambroise Paré · Cairo University · Carmel Medical Center · Celltrion HealthCare France · Center for Integrated Rehabilitation and Organ Failure Horn · Central South University · Changhai Hospital · Chiba University · City of Helsinki · all 264 on the full record

Regulatory milestones approvals, filings & regulatory actions · 20 recorded

Milestone	Jurisdiction	Brand	Indication	Date	Sentence it was read from
Filed immunodeficiency 112 1 milestone
Filed	EU (EMA)	—	immunodeficiency 112	2017-05-31	“Die Zulassungsanträge für die von Sandoz vorgeschlagenen Biosimilars Adalimumab (Humira® von AbbVie) und Infliximab (Remicade® von Janssen und Merck) wurden von der EMA zur...” novartis.com ↗ “the EMA has accepted for regulatory review our Marketing Authorization Applications for biosimilars to AbbVie's Humira ® (adalimumab) and Janssen's Remicade ® (infliximab)” novartis.com ↗ “EMA has accepted for regulatory review their Marketing Authorization Applications for biosimilars to AbbVie's Humira ® (adalimumab) and Janssen's Remicade ® (infliximab)” novartis.com ↗ “biosimilaires adalimumab (Humira® d'AbbVie) et infliximab (Remicade® de Janssen et de Merck) à l'EMA, qui a accepté de procéder à leur examen réglementaire.” novartis.com ↗ “Sandoz proposed biosimilars adalimumab (AbbVie's Humira ® ) and infliximab (Janssen and Merck's Remicade ® ) were accepted for regulatory review by EMA.” novartis.com ↗
Approved Indication not stated 6 milestones
Label expansion	US (FDA)	INFLECTRA	—	2019-06-18	fda.gov ↗
Filed	US (FDA)	—	—	2016-05-23	“FDA has accepted for review a Biologics License Application (BLA) submitted by Samsung Bioepis Co., Ltd. for SB2 (infliximab)” merck.com ↗
Filed	US (FDA)	Remsima	—	2014-08-08	“Celltrion announced that the company, on August 8, 2014, completed the filing procedure to obtain US FDA approval for its infliximab biosimilar.” celltrion.com ↗
Label expansions (14)	US (FDA)	REMICADE	—	1999-11-10 – 2011-09-23	fda.gov ↗
Approved	EU (EMA)	Remicade	—	1999-08-13	europa.eu ↗
Approved	US (FDA)	REMICADE	—	1998-08-24	fda.gov ↗

Trials 238 · started per year

today

US approved 1998

EU approved 1999

1995199619971998199920002001200220032004200520062007200820092010201120122013201420152016201720182019202020212022202320242025202620272028

Phase	Registry id	Dates	Indication	Sponsor	Status	Outcome
Phase 01 trial
Phase 0	NCT05663268	Oct 2022 → Mar 2023	hidradenitis suppurativa	Services Institute of Medical Sciences, Pakistan	Completed	No outcome recorded
Phase 111 trials · 2 met primary
Phase 1	NCT04779892	Feb → Jun 2020	rheumatoid arthritis	Taizhou Mabtech Pharmaceutical Co.,Ltd	Completed	No outcome recorded
Phase 1	NCT03446976	Feb → Jul 2018	—	Celltrion	Completed	No outcome recorded
Phase 1	NCT03293784	Oct 2017 → Dec 2019	melanoma	Institut Claudius Regaud	Completed	Met primary
Phase 1	NCT02987686	Sep 2017 → Nov 2025	corneal disorder	University of Montreal Hospital Centre (CHUM)	Completed	No outcome recorded
Phase 1	NCT02359903	Feb → Nov 2015	ankylosing spondylitis	Biocad	Completed	No outcome recorded
Phase 1	NCT01971814	Nov 2013 → Jan 2015	ulcerative colitis	University of California, San Francisco	Completed	No outcome recorded
Phase 1	NCT01922336	Jul → Oct 2013	—	Samsung Bioepis Co., Ltd.	Completed	Met primary
Phase 1	NCT00695682	Jun → Dec 2008	diabetic retinopathy, macular degeneration	Retina Research Foundation	Unknown	No outcome recorded
Phase 1	NCT00271570	Apr 2004 → Oct 2006	Kawasaki disease	University of California, San Diego	Completed	No outcome recorded
Phase 1	NCT00075075	Dec 2003 → Sep 2007	scleritis	National Eye Institute (NEI)	Completed	No outcome recorded
Phase 1	NCT00228839	? → Oct 2006	acute graft versus host disease	Emory University	Completed	No outcome recorded

Phase 1/210 trials
Phase 1/2	NCT02638701	Oct 2024 → Jun 2028 expected	brain aneurysm, stroke disorder, vasculitis	University of California, San Francisco	Recruiting	No outcome recorded
Phase 1/2	NCT06591273	Nov 2023 → Nov 2024 overdue	psoriasis	Services Institute of Medical Sciences, Pakistan	Active not recruiting	No outcome recorded
Phase 1/2	NCT05180994	May 2022 → Mar 2027 expected	glaucoma	University of Montreal Hospital Centre (CHUM)	Recruiting	No outcome recorded
Phase 1/2	NCT02126020	Nov 2014 → Apr 2017	Stevens-Johnson syndrome, mucous membrane pemphigoid	James Chodosh, MD, MPH	Withdrawn	No outcome recorded
Phase 1/2	NCT02620618	Jan 2013 → Dec 2014	Behcet disease, uveitis	Cairo University	Completed	No outcome recorded
Phase 1/2	NCT01256489	Dec 2010 → Jan 2015	Stevens-Johnson syndrome, corneal disorder	Massachusetts Eye and Ear Infirmary	Withdrawn	No outcome recorded
Phase 1/2	NCT00958906	Aug → Oct 2009	macular retinal edema, uveitis	Icahn School of Medicine at Mount Sinai	Withdrawn	No outcome recorded
Phase 1/2	NCT00959725	Aug 2009 → Aug 2011	diabetic macular edema	Icahn School of Medicine at Mount Sinai	Unknown	No outcome recorded
Phase 1/2	NCT00325078	May 2006 → Jun 2012	Crohn disease, chronic granulomatous disease	National Institute of Allergy and Infectious Diseases (NIAID)	Terminated	No outcome recorded
Phase 1/2	NCT00111917	Feb 2005 → Jan 2009	chronic beryllium disease	Maier, Lisa, M.D.	Terminated	No outcome recorded Stop: Enrollment
Phase 245 trials · 3 met primary · 8 missed
Phase 2	NCT07671222	Dec 2026 → Mar 2028 expected	Sjogren syndrome, dry eye syndrome	Instituto de Oftalmología Fundación Conde de Valenciana	Not yet recruiting	No outcome recorded
Phase 2	NCT07657312	Jul 2026 → Dec 2027 expected	cytokine release syndrome, plasma cell myeloma	Naresh Bumma	Recruiting	No outcome recorded
Phase 2	NCT07297069	Jan 2026 → May 2027 expected	ulcerative colitis	Asian Institute of Gastroenterology, India	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	NCT06453317	Feb 2025 → Apr 2028 expected	ulcerative colitis	Medical University of Lodz	Recruiting	No outcome recorded
Phase 2	NCT06136546	Jan 2025 → Aug 2028 expected	major depressive disorder	Massachusetts General Hospital	Recruiting	No outcome recorded
Phase 2	NCT05034536	Feb 2022 → Jun 2026 overdue	metastatic melanoma	Massachusetts General Hospital	Active not recruiting	No outcome recorded
Phase 2	NCT04922827	Jun 2021 → Mar 2023	COVID-19	Jena University Hospital	Completed	No outcome recorded
Phase 2	NCT04438382	Jan 2021 → Dec 2023	cancer, hematopoietic and lymphoid cell neoplasm	ECOG-ACRIN Cancer Research Group	Terminated	No outcome recorded Stop: Enrollment
Phase 2	NCT04564001	Sep 2020 → Feb 2021	Takayasu arteritis	Assistance Publique - Hôpitaux de Paris	Unknown	No outcome recorded
Phase 2	NCT04305145	Aug 2020 → Jun 2030 expected	chemical colitis, metastatic melanoma, poisoning, skin cancer	Massachusetts General Hospital	Active not recruiting	No outcome recorded
Phase 2	NCT04425538	Jun 2020 → Jan 2021	COVID-19	Tufts Medical Center	Completed	No outcome recorded
Phase 2	NCT04114188	Dec 2016 → Dec 2020	transplant rejection	Prof. Dr. Petra Reinke	Completed	Met primary
Phase 2	NCT02763761	Aug 2016 → Mar 2017	lung cancer, melanoma, renal cell carcinoma	Bristol-Myers Squibb	Withdrawn	No outcome recorded Stop: Enrollment
Phase 2	NCT02495077	Nov 2015 → Jul 2021	—	National Institute of Allergy and Infectious Diseases (NIAID)	Completed	Missed primary
Phase 2	NCT02363738	Sep 2015 → Apr 2017	bipolar depression	University Health Network, Toronto	Completed	Missed primary
Phase 2	NCT02457585	Mar 2015 → Aug 2017	Takayasu arteritis	Seoul National University Hospital	Unknown	No outcome recorded
Phase 2	NCT01485055	Dec 2011 → Dec 2015	acute graft versus host disease	Nationwide Children's Hospital	Terminated	No outcome recorded
Phase 2	NCT01355614	Jun 2011 → Mar 2013	Crohn disease	Novartis Pharmaceuticals	Completed	No outcome recorded
Phase 2	NCT01313520	Mar 2011 → Mar 2012	rheumatoid arthritis	Merck Sharp & Dohme LLC	Completed	Met primary
Phase 2	NCT01216631	Sep 2010 → Aug 2011	spondyloarthropathy	University of Leeds	Terminated	No outcome recorded Stop: Enrollment
Phase 2	NCT00823641	Oct 2008 → Mar 2011	tropical spastic paraparesis	Imperial College London	Terminated	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	NCT00523354	Aug → Sep 2007	esophagitis	Swiss EE Study Group	Completed	No outcome recorded
Phase 2	NCT00512278	Jul 2007 → May 2012	chronic hepatitis C virus infection	Nizar Zein	Completed	No outcome recorded
Phase 2	NCT00372723	Jul 2006 → Jun 2011	toxic epidermal necrolysis	Loyola University	Withdrawn	No outcome recorded Stop: Enrollment
Phase 2	NCT00687362	May 2006 → Nov 2008	psoriasis	Merck Sharp & Dohme LLC	Completed	No outcome recorded
Phase 2	NCT00283712	Mar 2006 → Dec 2010	pemphigus	National Institute of Allergy and Infectious Diseases (NIAID)	Completed	Missed primary
Phase 2	NCT00795574	Jun 2005 → Aug 2008	hidradenitis suppurativa	Florida Academic Dermatology Centers	Completed	No outcome recorded
Phase 2	NCT00112749	Feb 2005 → Jan 2007	breast cancer	Jonsson Comprehensive Cancer Center	Terminated	No outcome recorded Stop: Enrollment
Phase 2	NCT00604864	Feb 2004 → Feb 2005	endometriosis	KU Leuven	Completed	Missed primary
Phase 2	NCT00201799	Feb 2004 → Aug 2006	graft versus host disease	Ohio State University Comprehensive Cancer Center	Completed	Missed primary
Phase 2	NCT00076726	Nov 2003 → Jul 2005	temporal arteritis	Centocor, Inc.	Terminated	Missed primary
Phase 2	NCT00074074	Oct 2003 → Dec 2006	myelodysplastic syndrome	European Organisation for Research and Treatment of Cancer - EORTC	Completed	Missed primary
Phase 2	NCT00244192	Oct 2003 → Dec 2005	chronic obstructive pulmonary disease	Center for Integrated Rehabilitation and Organ Failure Horn	Completed	No outcome recorded
Phase 2	NCT00060502	Apr 2003 → Feb 2006	hypoproteinemia, hypercatabolic, pancreatic neoplasm	Centocor, Inc.	Completed	Missed primary
Phase 2	NCT00244179	Jan 2003 → ?	reactive arthritis	Charite University, Berlin, Germany	Unknown	No outcome recorded
Phase 2	NCT00753103	Jan 2003 → Jul 2006	granulomatosis with polyangiitis, microscopic polyangiitis	University Hospital Birmingham NHS Foundation Trust	Completed	No outcome recorded
Phase 2	NCT00033891	Apr 2002 → Jul 2007	dermatomyositis	National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)	Completed	No outcome recorded
Phase 2	NCT00029042	Jan 2002 → Oct 2005	polyarticular juvenile rheumatoid arthritis	National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)	Terminated	No outcome recorded
Phase 2	NCT00278083	Oct 2001 → Apr 2004	asthma	Imperial College London	Completed	No outcome recorded
Phase 2	NCT00006292	Sep 2000 → Sep 2005	rheumatoid arthritis	National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)	Completed	No outcome recorded
Phase 2	NCT00175266	—	type 1 diabetes mellitus	University of Alberta	Completed	No outcome recorded
Phase 2	NCT00230529	? → Jan 2003	psoriasis	Centocor, Inc.	Completed	Met primary

Phase 2/37 trials
Phase 2/3	NCT05660746	Jul 2023 → Mar 2027 expected	Crohn disease	Children's Hospital Medical Center, Cincinnati	Recruiting	No outcome recorded
Phase 2/3	NCT04974099	Oct 2021 → Aug 2024	Crohn disease	Children's Hospital Medical Center, Cincinnati	Terminated	No outcome recorded
Phase 2/3	NCT00521963	Mar 2010 → Mar 2011	arthritic joint disease	HaEmek Medical Center, Israel	Withdrawn	No outcome recorded Stop: Enrollment
Phase 2/3	NCT00368264	Sep 2006 → Jun 2009	lupus nephritis, systemic lupus erythematosus	Medical University of Vienna	Terminated	No outcome recorded Stop: Enrollment
Phase 2/3	NCT00591201	Jun 2002 → Jun 2007	spondyloarthropathy	Hospital General de Mexico	Completed	No outcome recorded
Phase 2/3	NCT00269854	Jun 1995 → Oct 1996	Crohn disease	Centocor, Inc.	Completed	No outcome recorded
Phase 2/3	NCT00443222	—	myositis disease	Karolinska Institutet	Completed	No outcome recorded
Phase 377 trials · 19 met primary · 7 missed
Phase 3	NCT06738719	Jan → Jun 2025	—	Celltrion	Completed	No outcome recorded
Phase 3	NCT06614387	Oct 2024 → Apr 2028 expected	ulcerative colitis	JAROSLAW KIERKUS	Not yet recruiting	No outcome recorded
Phase 3	NCT06274294	Jul 2024 → Jan 2025	inflammatory bowel disease	CMC Ambroise Paré	Unknown	No outcome recorded
Phase 3	NCT05947669	Aug 2023 → Sep 2026 overdue	colitis	Odense University Hospital	Recruiting	No outcome recorded
Phase 3	NCT05689879	Mar 2023 → Jan 2027 expected	sarcoidosis	Assistance Publique - Hôpitaux de Paris	Active not recruiting	No outcome recorded
Phase 3	NCT06059989	Nov 2021 → Jun 2025 overdue	Crohn disease, inflammatory disease	Academic Medical Center - University of Amsterdam	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	NCT04535518	Oct 2020 → Sep 2022	Kawasaki disease	Children's Hospital of Fudan University	Withdrawn	No outcome recorded Stop: Business
Phase 3	NCT04205643	Sep 2020 → Jul 2022	ulcerative colitis	Celltrion	Completed	Met primary
Phase 3	NCT03088293	Jun 2020 → Oct 2023	idiopathic scleritis	Hospices Civils de Lyon	Withdrawn	No outcome recorded Stop: Enrollment
Phase 3	NCT04330690	Mar 2020 → Mar 2024	COVID-19	Sunnybrook Health Sciences Centre	Unknown	Missed primary
Phase 3	NCT03945019	Oct 2019 → Aug 2022	Crohn disease	Celltrion	Completed	Met primary
Phase 3	NCT03704610	Mar 2019 → Jun 2021	sarcoidosis	Assistance Publique - Hôpitaux de Paris	Completed	No outcome recorded
Phase 3	NCT03704363	Dec 2018 → Jul 2023	—	Oslo University Hospital	Completed	No outcome recorded
Phase 3	NCT03596645	Oct 2018 → Nov 2023 overdue	ulcerative colitis	Janssen Research & Development, LLC	Active not recruiting	Met primary
Phase 3	NCT03371095	May 2018 → Dec 2021	Behcet disease, vasculitis	Assistance Publique - Hôpitaux de Paris	Completed	No outcome recorded
Phase 3	NCT02990806	Jan 2017 → May 2019	rheumatoid arthritis	Nichi-Iko Pharmaceutical Co., Ltd.	Completed	No outcome recorded
Phase 3	NCT02771457	Jul 2016 → Jul 2019	inflammatory bowel disease	NYU Langone Health	Withdrawn	No outcome recorded
Phase 3	NCT02505568	Jul 2015 → Jul 2018	Behcet disease	Janssen Korea, Ltd., Korea	Completed	No outcome recorded
Phase 3	NCT02096861	Sep 2014 → Jan 2016	Crohn disease	Celltrion	Completed	Met primary
Phase 3	NCT02298062	Jan 2013 → Jul 2015	Kawasaki disease	Fudan University	Completed	No outcome recorded
Phase 3	NCT01680159	Jul 2012 → Mar 2015	psoriatic arthritis, pustular psoriasis	Tanabe Pharma Corporation	Completed	No outcome recorded
Phase 3	NCT01596335	May 2012 → Oct 2014	Kawasaki disease	Tanabe Pharma Corporation	Completed	Met primary
Phase 3	NCT01551290	Apr 2012 → Mar 2014	ulcerative colitis	Xian-Janssen Pharmaceutical Ltd.	Completed	No outcome recorded
Phase 3	NCT01571219	Mar 2012 → Jul 2013	rheumatoid arthritis	Celltrion	Completed	No outcome recorded
Phase 3	NCT01580670	Mar 2012 → Mar 2015	Crohn disease	Tanabe Pharma Corporation	Completed	No outcome recorded
Phase 3	NCT01585155	Feb 2012 → Sep 2014	ulcerative colitis	Tanabe Pharma Corporation	Completed	No outcome recorded
Phase 3	NCT01532570	Jan 2012 → May 2014	Behcet disease	Tanabe Pharma Corporation	Completed	No outcome recorded
Phase 3	NCT01190839	Nov 2010 → Dec 2014	Crohn disease	Janssen Biotech, Inc.	Terminated	Missed primary
Phase 3	NCT00984568	Nov 2009 → Mar 2012	ulcerative colitis	Merck Sharp & Dohme LLC	Terminated	No outcome recorded Stop: Enrollment
Phase 3	NCT00833053	Oct 2009 → Apr 2011	psoriasis	Merck Sharp & Dohme LLC	Terminated	No outcome recorded Stop: Enrollment
Phase 3	NCT00844805	Sep 2009 → Apr 2011	ankylosing spondylitis	Merck Sharp & Dohme LLC	Completed	Met primary
Phase 3	NCT00760435	Mar 2009 → Oct 2012	Kawasaki disease	University of California, San Diego	Completed	Missed primary
Phase 3	NCT01177800	Feb 2009 → Feb 2010	psoriasis	Xian-Janssen Pharmaceutical Ltd.	Completed	Met primary
Phase 3	NCT02779114	Jan 2009 → Dec 2017	rheumatoid arthritis	University of Erlangen-Nürnberg Medical School	Unknown	No outcome recorded
Phase 3	NCT00805766	Dec 2008 → Nov 2009	Crohn disease	Tanabe Pharma Corporation	Completed	No outcome recorded
Phase 3	NCT00686686	Dec 2007 → Feb 2009	psoriasis	Merck Sharp & Dohme LLC	Completed	No outcome recorded
Phase 3	NCT00537316	Jul 2007 → Feb 2010	ulcerative colitis	Merck Sharp & Dohme LLC	Terminated	No outcome recorded
Phase 3	NCT00527072	Jul 2007 → May 2009	psoriasis	Centocor Ortho Biotech Services, L.L.C.	Completed	No outcome recorded
Phase 3	NCT01423591	Jun 2007 → Sep 2010	polymyalgia rheumatica	Hospital Universitario Marqués de Valdecilla	Unknown	No outcome recorded
Phase 3	NCT00521924	Jun 2007 → Apr 2008	rheumatoid arthritis	Merck Sharp & Dohme LLC	Terminated	No outcome recorded Stop: Enrollment
Phase 3	NCT00385086	Feb 2007 → Oct 2012	lumbar stenosis, familial	Assistance Publique - Hôpitaux de Paris	Completed	Missed primary
Phase 3	NCT00336492	Sep 2006 → May 2009	ulcerative colitis	Centocor, Inc.	Completed	No outcome recorded
Phase 3	NCT00732875	Aug 2006 → May 2008	rheumatoid arthritis	Merck Sharp & Dohme LLC	Completed	No outcome recorded
Phase 3	NCT00687401	Jun 2006 → May 2009	psoriasis	Merck Sharp & Dohme LLC	Completed	No outcome recorded
Phase 3	NCT00367237	May 2006 → Mar 2008	psoriatic arthritis	Merck Sharp & Dohme LLC	Completed	Met primary
Phase 3	NCT00358670	May 2006 → Jan 2009	psoriasis	Merck Sharp & Dohme LLC	Terminated	No outcome recorded
Phase 3	NCT00394589	Mar 2006 → Oct 2008	rheumatoid arthritis	Merck Sharp & Dohme LLC	Terminated	No outcome recorded Stop: Enrollment
Phase 3	NCT00571337	Dec 2005 → Jul 2010	Crohn disease	Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives	Completed	No outcome recorded
Phase 3	NCT00251641	Sep 2005 → Jun 2008	psoriasis	Merck Sharp & Dohme LLC	Completed	Met primary
Phase 3	NCT00691028	Sep 2005 → May 2007	rheumatoid arthritis	Tanabe Pharma Corporation	Completed	No outcome recorded
Phase 3	NCT00254982	Aug 2005 → Sep 2006	psoriasis	Merck Sharp & Dohme LLC	Completed	No outcome recorded
Phase 3	NCT00237484	Jul 2005 → Jun 2011	chronic hepatitis C virus infection	Merck Sharp & Dohme LLC	Completed	No outcome recorded
Phase 3	NCT00202852	Jun 2005 → Mar 2006	rheumatoid arthritis	Merck Sharp & Dohme LLC	Completed	Met primary
Phase 3	NCT00202865	May 2005 → May 2007	ankylosing spondylitis	Merck Sharp & Dohme LLC	Completed	Met primary
Phase 3	NCT00094458	Mar 2005 → Apr 2008	Crohn disease	Centocor Ortho Biotech Services, L.L.C.	Completed	Met primary
Phase 3	NCT00796250	Nov 2003 → Jan 2005	Crohn disease	Merck Sharp & Dohme LLC	Terminated	No outcome recorded Stop: Enrollment
Phase 3	NCT00073437	Oct 2003 → Feb 2005	sarcoidosis	Centocor, Inc.	Completed	No outcome recorded
Phase 3	NCT00317538	Jun 2003 → Nov 2004	rheumatoid arthritis	Centocor Ortho Biotech Services, L.L.C.	Completed	No outcome recorded
Phase 3	NCT01015547	May 2003 → Nov 2007	polyarticular juvenile idiopathic arthritis	Helsinki University Central Hospital	Completed	No outcome recorded
Phase 3	NCT00051623	May 2003 → Jun 2004	psoriatic arthritis	Centocor, Inc.	Completed	No outcome recorded
Phase 3	NCT00439283	Apr 2003 → Dec 2004	ankylosing spondylitis	Association de Recherche Clinique en Rhumatologie	Completed	Met primary
Phase 3	NCT00207675	Feb 2003 → Aug 2007	Crohn disease	Centocor, Inc.	Completed	No outcome recorded
Phase 3	NCT00106847	Jan 2003 → Jul 2005	parapsoriasis, psoriasis	Centocor, Inc.	Completed	No outcome recorded
Phase 3	NCT00056264	Dec 2002 → Dec 2004	chronic obstructive pulmonary disease	Centocor, Inc.	Completed	Missed primary
Phase 3	NCT00040885	Oct 2002 → Feb 2006	eating disorder, lung cancer	Alliance for Clinical Trials in Oncology	Completed	Missed primary
Phase 3	NCT00207701	Sep 2002 → Feb 2005	ankylosing spondylitis	Centocor, Inc.	Completed	Met primary
Phase 3	NCT00096655	May 2002 → Aug 2007	ulcerative colitis	Centocor, Inc.	Completed	No outcome recorded
Phase 3	NCT00036439	Feb 2002 → Jan 2007	ulcerative colitis	Centocor, Inc.	Completed	Met primary
Phase 3	NCT00036374	Oct 2001 → Dec 2006	juvenile idiopathic arthritis	Centocor, Inc.	Completed	Missed primary
Phase 3	NCT00207662	Jul 2000 → Nov 2005	Crohn disease	Centocor, Inc.	Completed	Met primary
Phase 3	NCT00207766	Jun 2000 → Aug 2006	Crohn disease	Centocor, Inc.	Completed	Met primary
Phase 3	NCT00269867	Mar 1997 → Mar 2000	rheumatoid arthritis	Centocor, Inc.	Completed	No outcome recorded
Phase 3	NCT00269841	May 1996 → Feb 1998	Crohn disease	Centocor, Inc.	Completed	Met primary
Phase 3	NCT00036387	? → Nov 2003	rheumatoid arthritis	Centocor, Inc.	Completed	No outcome recorded
Phase 3	NCT00236028	? → Apr 2003	rheumatoid arthritis	Centocor, Inc.	Completed	No outcome recorded
Phase 3	NCT00106834	? → Oct 2004	psoriasis	Centocor, Inc.	Completed	Met primary

Phase 469 trials · 6 met primary · 1 missed
Phase 4	NCT07576452	Dec 2026 → Jun 2030 expected	ulcerative colitis	University Hospital, Clermont-Ferrand	Not yet recruiting	No outcome recorded
Phase 4	NCT07683975	Sep 2026 → Jan 2029 expected	acute kidney injury, acute tubulointerstitial nephritis	Massachusetts General Hospital	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	NCT07510191	Mar 2026 → Dec 2028 expected	Crohn disease	Sixth Affiliated Hospital, Sun Yat-sen University	Recruiting	No outcome recorded
Phase 4	NCT05823532	Apr 2024 → Mar 2028 expected	schizophrenia	Emory University	Recruiting	No outcome recorded
Phase 4	NCT06051253	Nov 2023 → Jun 2026 overdue	perianal Crohn disease	Asan Medical Center	Recruiting	No outcome recorded
Phase 4	NCT05906576	Sep 2023 → Nov 2026 expected	Crohn disease	Taizhou Mabtech Pharmaceutical Co.,Ltd	Recruiting	No outcome recorded
Phase 4	NCT05552287	Aug 2023 → Aug 2025 overdue	Crohn disease	Erasmus Medical Center	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	NCT05813860	Apr 2023 → May 2026 overdue	Crohn disease	Sixth Affiliated Hospital, Sun Yat-sen University	Not yet recruiting	No outcome recorded
Phase 4	NCT05169593	Sep 2022 → Oct 2027 expected	Crohn disease	Universitaire Ziekenhuizen KU Leuven	Recruiting	No outcome recorded
Phase 4	NCT06043752	Mar 2022 → Jul 2023	psoriasis	Ghurki Trust and Teaching Hospital	Completed	No outcome recorded
Phase 4	NCT05280405	Mar 2022 → Jan 2024	inflammatory bowel disease	IRCCS Burlo Garofolo	Unknown	No outcome recorded
Phase 4	NCT05220280	Feb 2022 → Dec 2024	COVID-19	Clinical Urology and Epidemiology Working Group	Unknown	No outcome recorded
Phase 4	NCT05164198	Jan 2022 → Oct 2024	ankylosing spondylitis	Hanyang University Seoul Hospital	Unknown	No outcome recorded
Phase 4	NCT05273242	Dec 2021 → Dec 2022	COVID-19	Nepal Health Research Council	Unknown	No outcome recorded
Phase 4	NCT05115903	Dec 2021 → Jul 2024	spondyloarthropathy	University Health Network, Toronto	Unknown	No outcome recorded
Phase 4	NCT04999228	Nov 2021 → Jun 2025 overdue	ulcerative colitis	Children's Hospital of Fudan University	Recruiting	No outcome recorded
Phase 4	NCT04835506	Nov 2021 → Sep 2026 overdue	Crohn disease, ulcerative colitis	Beth Israel Deaconess Medical Center	Active not recruiting	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	NCT05340764	Aug 2020 → May 2023	inflammatory bowel disease	Washington University School of Medicine	Completed	Met primary
Phase 4	NCT03937609	Sep 2019 → Dec 2024	ulcerative colitis	Academic Medical Center - University of Amsterdam	Terminated	No outcome recorded Stop: Enrollment
Phase 4	NCT03679546	Jan 2019 → Dec 2024	ulcerative colitis	Rennes University Hospital	Completed	No outcome recorded
Phase 4	NCT04775732	Jun 2018 → Aug 2019	Crohn disease, ulcerative colitis	Imelda GI Clinical Research Center	Completed	No outcome recorded
Phase 4	NCT03004443	May 2017 → Nov 2019	depressive disorder	Emory University	Terminated	No outcome recorded
Phase 4	NCT04150770	Jan 2017 → Jan 2020	uveitis	Xiaomin Zhang	Unknown	No outcome recorded
Phase 4	NCT03006393	Aug 2016 → Sep 2020	depressive disorder	Emory University	Completed	No outcome recorded
Phase 4	NCT02770794	Apr 2016 → Aug 2020	rheumatoid arthritis	Chiba University	Completed	No outcome recorded
Phase 4	NCT02566889	Apr 2016 → Jul 2019	inflammatory bowel disease	Janssen Scientific Affairs, LLC	Terminated	No outcome recorded Stop: Enrollment
Phase 4	NCT02714634	Mar 2016 → Mar 2029 expected	rheumatoid arthritis	University Hospital, Strasbourg, France	Recruiting	No outcome recorded
Phase 4	NCT02878161	Jan 2016 → Dec 2019	rheumatoid arthritis	Fen Li	Unknown	No outcome recorded
Phase 4	NCT02177071	Oct 2015 → Jun 2021	Crohn disease	Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives	Completed	No outcome recorded
Phase 4	NCT02453776	May 2015 → Dec 2018	inflammatory bowel disease	Academic Medical Center - University of Amsterdam	Completed	Met primary
Phase 4	NCT02517684	Apr 2015 → Dec 2019	Crohn disease	Erasmus Medical Center	Completed	Met primary
Phase 4	NCT02148640	Oct 2014 → Jun 2016	Crohn disease, psoriasis, psoriatic arthritis, spondyloarthropathy +1	Diakonhjemmet Hospital	Completed	Met primary
Phase 4	NCT02132234	Jun 2013 → Jul 2014	ankylosing spondylitis, hypertensive disorder, psoriatic arthritis	Jagiellonian University	Unknown	No outcome recorded
Phase 4	NCT01880307	Jan 2013 → Dec 2014	Crohn disease	Erasmus Medical Center	Terminated	No outcome recorded
Phase 4	NCT01752790	Dec 2012 → Jan 2014	Crohn disease	University of Roma La Sapienza	Withdrawn	No outcome recorded
Phase 4	NCT01604629	Jul 2012 → Apr 2015	spondyloarthropathy	Spanish Clinical Pharmacology Society	Completed	Met primary
Phase 4	NCT01181765	Jun 2012 → Jan 2013	small bowel Crohn disease	Janssen, LP	Completed	No outcome recorded
Phase 4	NCT01602302	Jun 2012 → Nov 2020	rheumatoid arthritis	Medical University of Graz	Terminated	No outcome recorded Stop: Enrollment
Phase 4	NCT01638715	May 2012 → Aug 2018	rheumatoid arthritis	Medical University of Vienna	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	NCT01408810	Feb 2011 → Nov 2012	ulcerative colitis	Grupo de Estudo da Doença Inflamatória Intestinal	Completed	No outcome recorded
Phase 4	NCT01282528	Sep 2010 → ?	rheumatoid arthritis	Peking Union Medical College Hospital	Unknown	No outcome recorded
Phase 4	NCT01148901	Jun → Dec 2010	ankylosing spondylitis	Merck Sharp & Dohme LLC	Withdrawn	No outcome recorded Stop: Enrollment
Phase 4	NCT00463580	Dec 2008 → Jun 2011	depressive disorder	Emory University	Completed	Missed primary
Phase 4	NCT00752622	Nov 2008 → Jun 2010	Crohn disease	Merck Sharp & Dohme LLC	Terminated	No outcome recorded Stop: Enrollment
Phase 4	NCT00714493	Jul 2008 → Jan 2010	rheumatoid arthritis	Centocor Ortho Biotech Services, L.L.C.	Completed	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	NCT00936143	Jan 2008 → Sep 2009	spondylitis	Gu Jieruo	Completed	No outcome recorded
Phase 4	NCT00686894	Jan → Nov 2008	ankylosing spondylitis	Merck Sharp & Dohme LLC	Terminated	No outcome recorded Stop: Enrollment
Phase 4	NCT00686595	Oct 2007 → Oct 2009	psoriasis	Merck Sharp & Dohme LLC	Completed	No outcome recorded
Phase 4	NCT00507403	Oct 2007 → Oct 2009	ankylosing spondylitis	University Hospital, Tours	Completed	No outcome recorded
Phase 4	NCT01144143	Jul 2007 → Dec 2010	osteoarthritis, knee	Herbert Lindsley, MD	Completed	No outcome recorded
Phase 4	NCT00896168	Jun 2007 → Apr 2008	rheumatoid arthritis	Xian-Janssen Pharmaceutical Ltd.	Completed	No outcome recorded
Phase 4	NCT00462072	Mar 2007 → Jun 2010	Crohn disease, psoriasis, psoriatic arthritis	University of Rochester	Completed	No outcome recorded
Phase 4	NCT01308255	Sep 2006 → Feb 2011	rheumatoid arthritis	University of Leeds	Completed	No outcome recorded
Phase 4	NCT00574470	Jan 2006 → Nov 2007	graft versus host disease	University of Iowa	Completed	No outcome recorded
Phase 4	NCT00216177	Sep 2005 → Jan 2009	rheumatoid arthritis	Hvidovre University Hospital	Unknown	No outcome recorded
Phase 4	NCT00778869	Aug 2005	ankylosing spondylitis	Merck Sharp & Dohme LLC	Completed	No outcome recorded
Phase 4	NCT00779012	Oct 2004 → Jun 2007	ankylosing spondylitis	Merck Sharp & Dohme LLC	Completed	No outcome recorded
Phase 4	NCT00779935	Oct 2004 → Oct 2005	ankylosing spondylitis	Merck Sharp & Dohme LLC	Completed	No outcome recorded
Phase 4	NCT00133315	Sep 2004 → Apr 2007	ankylosing spondylitis, psoriatic arthritis	Hvidovre University Hospital	Completed	No outcome recorded
Phase 4	NCT00794898	Jul 2003 → Apr 2004	rheumatoid arthritis	Merck Sharp & Dohme LLC	Completed	No outcome recorded
Phase 4	NCT00246064	Dec 2001 → Nov 2003	rheumatoid arthritis	Centocor Ortho Biotech Services, L.L.C.	Completed	No outcome recorded
Phase 4	NCT00554710	May 2001 → Jan 2004	Crohn disease	Belgian Inflammatory Bowel Disease Research and Development (BIRD) VZW	Completed	Met primary

Phase not applicable18 trials
—	NCT05584228	Oct 2026 → Apr 2030 expected	Crohn disease	Nantes University Hospital	Not yet recruiting	No outcome recorded
—	NCT07424040	Mar 2026 → Nov 2028 expected	Crohn disease	The Children's Hospital of Zhejiang University School of Medicine	Not yet recruiting	No outcome recorded
—	NCT07176754	Oct 2025 → Jul 2028 expected	cardiac arrest, post-cardiac arrest syndrome	Peking University Third Hospital	Active not recruiting	No outcome recorded
—	NCT07491913	Jun 2025 → Dec 2027 expected	Takayasu arteritis	Marmara University	Recruiting	No outcome recorded
—	NCT06758024	Jan 2025 → Jan 2026 overdue	Crohn disease, ulcerative colitis	Pontificia Universidad Catolica de Chile	Recruiting	No outcome recorded
—	NCT06064864	Oct 2023 → Dec 2026 expected	Crohn disease	Asan Medical Center	Recruiting	No outcome recorded
—	NCT04378621	Oct 2020 → Sep 2025	depressive disorder, rheumatoid arthritis, subjective cognitive decline	Vastra Gotaland Region	Unknown	No outcome recorded
—	NCT03209232	Apr 2018 → Sep 2021	ulcerative colitis	Schneider Children's Medical Center, Israel	Terminated	No outcome recorded Stop: Enrollment
—	NCT03370601	Jan 2017 → Jan 2019	inflammatory bowel disease	University Hospital, Lille	Terminated	No outcome recorded Stop: Enrollment
—	NCT02522169	Sep 2015 → Dec 2016	Crohn disease	Klinikum Westbrandenburg GmbH	Unknown	No outcome recorded
—	NCT01915537	Aug 2013 → Dec 2015	rheumatoid arthritis	Zhang, Xiao, M.D.	Unknown	No outcome recorded
—	NCT01438151	Dec 2011 → Dec 2013	Crohn disease	Shradha Agarwal	Terminated	No outcome recorded Stop: Enrollment
—	NCT01361542	Feb → Dec 2011	ankylosing spondylitis	All India Institute of Medical Sciences	Completed	No outcome recorded
—	NCT01266785	Dec 2010 → Jul 2012	Crohn disease	Oregon Health and Science University	Withdrawn	No outcome recorded Stop: Enrollment
—	NCT00791557	Oct 2008 → Dec 2009	Crohn disease, pyoderma gangrenosum, ulcerative colitis	University Hospitals Cleveland Medical Center	Completed	No outcome recorded
—	NCT01245361	Nov 2007 → Dec 2011	arthritic joint disease	Patrick Durez	Completed	No outcome recorded
—	NCT00237419	Dec 2005 → Nov 2010	ankylosing spondylitis	Rheumazentrum Ruhrgebiet	Unknown	No outcome recorded
—	NCT00273390	Aug 2001 → Dec 2006	uveitis	Oregon Health and Science University	Completed	No outcome recorded

Comparator or background therapy111 trials
Phase 1	NCT05912712 Background	Jul 2023 → Jun 2025	solitary rectal ulcer syndrome, ulcerative colitis	Xijing Hospital of Digestive Diseases	Unknown	No outcome recorded
Phase 1	NCT03819296 Background	Feb 2021 → Oct 2026 expected	colitis, cutaneous melanoma, lung carcinoma in situ, malignant urinary system neoplasm +1	M.D. Anderson Cancer Center	Recruiting	No outcome recorded
Phase 1	NCT02883452 Comparator	Sep 2016 → Feb 2019	Crohn disease, ulcerative colitis	Celltrion	Completed	No outcome recorded
Phase 1	NCT01931189 Comparator	Aug 2013 → Jan 2014	—	Nichi-Iko Pharmaceutical Co., Ltd.	Completed	No outcome recorded
Phase 1	NCT01844804 Comparator	May → Nov 2013	—	Pfizer	Completed	Met primary
Show all 111 trials opens the full record — a long page

News releases announcing trial results or a regulatory action · 84

Date	Issuer	Release
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.
2026-02-19	Celltrion	Results New ECCO data show subcutaneous (SC) infliximab (Remsima™ SC) effectively recaptures and maintains disease control after drug holiday celltrion.com ↗ The results demonstrated that SC infliximab provides an effective and safe option to regain clinical control after a planned or unplanned treatment interruption
2025-11-26	Celltrion	Results Celltrion announces publication of post-hoc analysis of LIBERTY-CD study of ZYMFENTRA® (infliximab-dyyb), indicating consistent efficacy across disease location, including the terminal ileum in Clinical Gastroenterology and Hepatology journal celltrion.com ↗ The consistent clinical and endoscopic outcomes observed with subcutaneous formulation of infliximab, regardless of disease location, suggest its potential as an effective therapy across different ileocolonic segments.
2025-11-18	Celltrion	Regulatory European Commission Grants Approval of Remsima™ IV Liquid Formulation, World’s First Liquid Formulation of IV Infliximab celltrion.com ↗ Celltrion, Inc. today announced that the European Commission (EC) has granted marketing authorization for Remsima™ IV (intravenous) liquid formulation, the world’s first liquid formulation of IV infliximab.
2025-10-06	Celltrion	Results Celltrion Presents Positive Real-World Data on Switching from intravenous (IV) to subcutaneous (SC) infliximab at UEG Week 2025 Meet the Expert sessions celltrion.com ↗ Professor Nicolas Mathieu presented a real-life study which demonstrated that the switch from IV infliximab to SC infliximab is well tolerated amongst patients.
2025-02-21	Celltrion	Results Celltrion Unveils New Post-Hoc Analyses of LIBERTY Studies at the 20th ECCO Congress Further Evaluating the Efficacy and Safety of Subcutaneous (SC) Infliximab celltrion.com ↗ New data highlights the effectiveness of SC infliximab in achieving endoscopic-histologic remission in UC and clinical and endoscopic improvement in CD across all disease locations
2024-10-30	Celltrion	Results Celltrion presents post hoc analysis of LIBERTY studies of ZYMFENTRA® (infliximab-dyyb) at the American College of Gastroenterology 2024 Annual Scientific Meeting celltrion.com ↗ The data demonstrate that clinical outcomes for patients treated with ZYMFENTRA monotherapy were comparable to those for patients on combination therapy with immunosuppressants (IS), suggesting that monotherapy could be a potential treatment option for patients with inflammatory bowel disease (IBD).
2024-10-15	Celltrion	Results Celltrion presents 2-year post-hoc analysis findings for subcutaneous infliximab (CT-P13 SC), highlighting dose escalation as an option for managing loss of response in inflammatory bowel disease celltrion.com ↗ Celltrion today announced two-year results of subcutaneous infliximab (CT-P13 SC) dose escalation therapy at United European Gastroenterology (UEG) Week 2024 in Vienna.
2024-05-21	Celltrion	Results ZYMFENTRA™ (infliximab-dyyb) demonstrated long-term efficacy and safety profile of maintenance treatment through two years for adults with moderately to severely active Crohn's disease and ulcerative colitis celltrion.com ↗
2024-02-24	Celltrion	Results Celltrion presents new two-year data for subcutaneous infliximab (CT-P13 SC) in inflammatory bowel disease (IBD) at the 19th ECCO Congress celltrion.com ↗ Celltrion today presented positive two-year results from the extended LIBERTY studies (LIBERTY-CD1 and LIBERTY-UC2) in patients with moderately to severely active Crohn’s disease (CD) and ulcerative colitis (UC).
2023-10-23	Celltrion	Regulatory Celltrion USA Announces U.S. FDA Approval of ZYMFENTRA™ (infliximab-dyyb), the First and Only Subcutaneous infliximab, for the Treatment of People With Inflammatory Bowel Disease celltrion.com ↗ ZYMFENTRA™ is the first and only FDA-approved subcutaneous (SC) formulation of infliximab approved for the maintenance treatment of adult patients with moderately to severely active ulcerative colitis and Crohn’s disease
2023-10-17	Celltrion	Results Data Presented at UEG Week 2023 Further Support the Potential of Celltrion’s Investigational Subcutaneous Infliximab CT-P13 SC in the Treatment of Inflammatory Bowel Disease celltrion.com ↗ SC infliximab had a similar safety profile to the placebo during the maintenance period.
2023-03-03	Celltrion	Results Celltrion Healthcare Presents Efficacy and Safety Data From Global Phase III LIBERTY Trial, at the 18th ECCO Congress celltrion.com ↗ Today, Celltrion Healthcare presented new data demonstrating the efficacy and safety of subcutaneous (SC) infliximab (CT-P13 SC) in patients with inflammatory bowel disease (IBD).
2022-12-22	Celltrion	Regulatory Celltrion USA announces submission of the Biologics License Application (BLA) of novel subcutaneous formulation of CT-P13 to U.S. Food and Drug Administration celltrion.com ↗ Celltrion USA announces submission of the Biologics License Application (BLA) of novel subcutaneous formulation of CT-P13 to U.S. Food and Drug Administration
2022-06-02	Celltrion	Results New data show statistically greater improvements in clinical outcomes with subcutaneous infliximab, compared to intravenous infliximab celltrion.com ↗ New data show statistically greater improvements in clinical outcomes with subcutaneous infliximab, compared to intravenous infliximab
2022-03-02	Celltrion	Results Switching to subcutaneous infliximab leads to higher trough level and low risk of relapse in patients with inflammatory bowel disease celltrion.com ↗ Today, Celltrion Healthcare announced two new data sets on the SC formulation of infliximab, Remsima® (CT-P13) in IBD, at the European Crohn’s and Colitis Organisation (ECCO) virtual congress 2022.
2021-06-02	Celltrion	Regulatory Celltrion Healthcare Presents Positive One-Year Data for the First High-Concentration, Low-Volume and Citrate-Free Biosimilar Adalimumab YuflymaTM celltrion.com ↗
2021-03-31	Celltrion	Regulatory Celltrion Healthcare receives positive CHMP opinion for Remsima® SC for direct use of subcutaneous therapy without IV loading celltrion.com ↗ Celltrion Healthcare today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended Remsima® SC for direct use of subcutaneous therapy without IV loading in patients with rheumatoid arthritis (RA).
2020-10-27	Samsung Bioepis Co., Ltd.	Results 삼성바이오에피스, 미국 시장에서의 첫 제품 처방 연구결과 발표 samsungbioepis.com ↗ 그 결과 1년 이상의 처방 유지율(continuation rate)은 83% 였으며, 같은 성분 제품들에서 ‘렌플렉시스’로 안전하게 전환되었음을 확인할 수 있었다.
2020-10-14	Towa Pharmaceutical Co.,Ltd.	Regulatory インフリキシマブBS点滴静注用100mg「CTH」効能又は効果、用法及び用量追加承認取得のお知らせ towayakuhin.co.jp ↗ セルトリオン・ヘルスケア・ジャパン株式会社（本社：東京、代表取締役：チョイ・ジュシク、以下「セルトリオン」）と東和薬品株式会社（本社：大阪、代表取締役社長：吉田逸郎、以下「東和薬品」）は、セルトリオンと東和薬品が日本国内で共同販売しているインフリキシマブBS 点滴静注用 100mg 「 CTH 」について、 2020 年 10 月 14 日付で「強直性脊椎炎」の効能又は効果、用法及び用量の追加に係る承認事項一部変更承認を取得いたしましたので、お知らせいたします。
2020-10-10	Celltrion	Results New data presented at UEG Week Virtual 2020 show positive association between Remsima® SC pre-dose level with efficacy outcomes celltrion.com ↗ The results show a positive association between CT-P13 SC exposure with both efficacy and FC outcomes in patients with Crohn’s disease (CD) and ulcerative colitis (UC).
2020-07-27	Celltrion	Regulatory European Commission grants marketing authorisation for world’s first subcutaneous formulation of infliximab, Remsima® SC, for an additional five indic celltrion.com ↗ Celltrion Healthcare today announced that the European Commission (EC) has granted marketing authorisation for Remsima® (infliximab, CT-P13) subcutaneous (SC) formulation for the treatment of adult patients with ankylosing spondylitis, Crohn’s disease, ulcerative colitis, psoriatic arthritis and psoriasis.
2020-06-29	Celltrion	Regulatory Celltrion Healthcare receives positive CHMP opinion for an additional five indications for Remsima® SC including for use in inflammatory bowel disease celltrion.com ↗ Celltrion Healthcare receives positive CHMP opinion for an additional five indications for Remsima® SC including for use in inflammatory bowel disease
2020-06-04	Celltrion	Results Celltrion Healthcare showcases positive 1-year data and budget impact analysis for novel subcutaneous formulation of infliximab in patients celltrion.com ↗ The first study demonstrated no impact of body mass index (BMI) on clinical response to CT-P13 SC in patients with active rheumatoid arthritis (RA).
2020-02-14	Celltrion	Results Celltrion Healthcare showcases positive 1-year results for novel subcutaneous formulation of infliximab in patients with active CD and UC celltrion.com ↗ In the study, 131 patients were randomised at the maintenance phase (66 to the SC arm and 65 to the IV arm), of whom 105 (80.2%) patients completed the week 54 visit (55 in the SC arm and 50 in the IV arm).
2019-12-06	Amgen	Regulatory FDA Approves Amgen's AVSOLA™ (infliximab-axxq), For The Same Indications As Remicade® (infliximab) amgen.com ↗ today announced that the U.S. Food and Drug Administration ( FDA ) has approved AVSOLA™ (infliximab-axxq)
2019-11-26	Celltrion	Regulatory Celltrion Healthcare receives EU marketing authorisation for world’s first subcutaneous formulation of infliximab, Remsima SC™, for the treatment of p celltrion.com ↗ Celltrion Healthcare todayannounced that the European Commission has approved Remsima SC™(CT-P13 SC, biosimilar infliximab) for patients with RA.[1]
2019-11-09	Celltrion	Results New data show non-inferiority of efficacy for subcutaneous formulation of CT-P13 (biosimilar infliximab) to intravenous formulation of CT-P13 in peopl celltrion.com ↗ The results after switching from intravenous (IV) to subcutaneous (SC) treatment at Week 30 were comparable with that of maintaining CT-P13 SC up to Week 54 (up to Week 64 for safety profile)1
2019-10-22	Samsung Bioepis Co., Ltd.	Results 삼성바이오에피스, 유럽 학회에서 환자 처방 데이터 발표 samsungbioepis.com ↗ 추가로, 삼성바이오에피스는 기존에 인플릭시맙 성분 의약품을 처방받지 않았거나 다른 인플릭시맙으로부터 전환 처방된 환자들에게 플릭사비를 처방했을 때, 면역원성 등에서 우려되는 사항이 발생하지 않고 성공적으로 전환되었음을 확인했다.9)
2019-10-21	Biogen	Results Biogen and Samsung Bioepis to Present Data for Infliximab and Adalimumab Biosimilars at United European Gastroenterology Week biogen.com ↗ In this real-world cohort of IBD patients transitioning from one infliximab biosimilar (CT-P13) to another (FLIXABI), showed similar effectiveness and safety.
2019-10-18	Celltrion	Results New subcutaneous formulation of Celltrion Healthcare’s CT-P13 (biosimilar infliximab) shows positive Phase 1 results for the treatment of IBD in data celltrion.com ↗ The Phase 1 pivotal study demonstrated that CT-P13 SC showed non-inferiority in PK to CT-P13 IV as determined by the trough concentration, pre-dose level (Ctrough) at week 22.
2019-09-22	Celltrion	Regulatory Celltrion Healthcare receives CHMP positive opinion for novel subcutaneous formulation of CT-P13 (biosimilar infliximab) for the treatment of people w celltrion.com ↗ This recommendation will now be reviewed by the European Commission, which has the authority to approve medicines in the EU.
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)
2019-06-12	Celltrion	Results New Subcutaneous Formulation of Celltrion Healthcare’s CT-P13 (biosimilar infliximab) Shows Positive Results for the Treatment of Rheumatoid Arthriti celltrion.com ↗ Overall, the efficacy results of CT-P13 SC up to week 54 were comparable to those of CT-P13 IV.
2019-03-08	Celltrion	Results Celltrion Healthcare showcases initial data from year-long study for subcutaneous formulation of CT-P13 (biosimilar infliximab) in patients with Crohn celltrion.com ↗ From week 6 to week 30, the results showed comparable overall clinical response of CT-P13 SC to CT-P13 IV with similar CDAI-70 scores, whereas clinical remission appears to be numerically higher in the SC cohorts at week 54.
2018-12-03	Celltrion	Regulatory European Medicines Agency Accepts Extension Marketing Authorisation Application for Review of Celltrion’s Remsima SC, the subcutaneous version of Rems celltrion.com ↗ Celltrion, Inc. (KRX:068270) today announced that the European Medicines Agency (EMA) has accepted for review of the Extension Marketing Authorisation Application for ‘Remsima SC’, the subcutaneous (SC) version of Remsima®, the autoimmune disease therapeutic antibody biosimilar of infliximab.
2018-06-15	Novartis Pharmaceuticals	Results Sandoz presents new long-term and switching data for biosimilars Zessly® (infliximab) and Erelzi® (etanercept) in rheumatoid arthritis novartis.com ↗ The research demonstrated that there were no clinically-meaningful differences from 30 to 54 weeks in terms of safety, efficacy and immunogenicity between patients with rheumatoid arthritis remaining on Sandoz infliximab and reference infliximab.
2018-06-13	Celltrion	Results Celltrion Healthcare showcases promising preliminary results for new subcutaneous version of infliximab in patients with rheumatoid arthritis celltrion.com ↗ The safety profiles in the SC version of infliximab cohorts were comparable to CT-P13 IV.
2018-06-05	Celltrion	Results Celltrion Healthcare’s new subcutaneous version of infliximab shows positive results for the treatment of active Crohn’s disease in data presented at celltrion.com ↗ The 30-week results from the study showed comparable efficacy of SC version of infliximab to CT-P13 IV with a similar rate of clinical remissions and changes from baseline of CDAI, CDAI-70 and CDAI-100 scores - standardised disease improvement measurements used to quantify the symptoms of active CD.
2018-05-24	Novartis Pharmaceuticals	Regulatory Sandoz receives European Commission approval for Zessly® (infliximab) in gastroenterological, rheumatological and dermatological diseases novartis.com ↗ Sandoz, a Novartis division and the global leader in biosimilars, today announced that the European Commission (EC) has approved Zessly ® (infliximab) for use in Europe.
2018-03-23	Novartis Pharmaceuticals	Regulatory Sandoz receives positive CHMP opinion for proposed biosimilar infliximab novartis.com ↗
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.
2017-12-13	Pfizer	Regulatory FDA Approves New Pfizer Biosimilar pfizer.com ↗ Pfizer Inc. (NYSE:PFE) announced today that the United States (U.S.) Food and Drug Administration (FDA) has approved IXIFI™ (PF-06438179, infliximab-qbtx), a chimeric human-murine monoclonal antibody (mAb) against tumor necrosis factor, as a biosimilar to Remicade® (infliximab)* for all eligible indications of the reference product.
2017-10-30	Celltrion	Results Celltrion Healthcare present 1-year results for CT-P13 (biosimilar infliximab, Remsima®/ Inflectra®) switching study in Crohn’s disease celltrion.com ↗ The data showed comparable efficacy and safety between all treatment groups (maintained and switched) in patients with moderate to severe Crohn’s disease (CD) up to one year.[1]
2017-10-29	Pfizer	Results One Year Maintenance and Switching Data in Patients with Crohn’s Disease Support the Use of INFLECTRA®* (infliximab CT-P13) in IBD1 pfizer.com ↗ New data show that switching patients with Crohn’s disease (CD) to INFLECTRA (infliximab CT-P13) from REMICADE (infliximab) led to comparable efficacy, safety and tolerability to treatment with REMICADE over a 24 week period.
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.
2017-02-20	Celltrion	Results The primary outcome from a RCT in Crohn’s disease shows biosimilar infliximab is comparable to reference infliximab in terms of efficacy and safety celltrion.com ↗ The data indicate that the safety and efficacy of CT-P13 in patients with moderate-to-severe Crohn’s disease (CD) is comparable to those treated with reference infliximab.
2017-02-17	Pfizer	Results New Data in Crohn’s Disease Patients Shows Similar Efficacy and Safety Profiles for INFLECTRA® and REMICADE®a pfizer.com ↗ The randomized 54 week clinical trial (RCT) 2 in 214 patients met its primary end point demonstrating that, at six weeks, INFLECTRA was similar to REMICADE in the treatment of CD thereby meeting the criterion for non-inferiority.
2017-02-17	Celltrion	Results Celltrion Healthcare releases positive results from pivotal study in Crohn’s disease celltrion.com ↗ The data indicate that the safety and efficacy of CT-P13 in patients with moderate-to-severe Crohn’s disease (CD) is comparable to those treated with reference infliximab.
2017-01-20	Celltrion	Results Lancet Publishes Full Data-Set from Influential NOR-SWITCH Study celltrion.com ↗ The results demonstrate that CT-P13 is not inferior to continued treatment with the reference product and that patients can be safely switched.
2016-11-14	Celltrion	Results Celltrion Healthcare showcases data supporting efficacy and safety of both CT-P10 and CT-P13 biosimilars celltrion.com ↗ We have conducted studies that consistently demonstrate the equivalence and comparability of our biosimilar infliximab CT-P13 to the originator infliximab and are proud to be able to present similar data for our second biosimilar CT-P10.
2016-10-20	Celltrion	Results Celltrion announces Norwegian government-led switching clinical results for ‘Remsima’ celltrion.com ↗ New data presented at the 2016 United European Gastroenterology (UEG) Week show that a switch to biosimilar infliximab (CT-P13) from originator infliximab is not inferior to continued treatment with the originator and that patients can be safely switched.
2016-10-19	Celltrion	Results Norwegian government’s independent NOR-SWITCH study supports switching to biosimilar infliximab from originator celltrion.com ↗ New data presented at the 2016 United European Gastroenterology (UEG) Week show that a switch to biosimilar infliximab (CT-P13) from originator infliximab is not inferior to continued treatment with the originator and that patients can be safely switched.
2016-09-16	Pfizer	Results Pfizer Announces Positive Top-Line Results from REFLECTIONS B537-02 Study for PF-06438179 (infliximab-Pfizer) a Potential Biosimilar to Remicade® (infliximab) pfizer.com ↗ The trial demonstrated equivalent efficacy of the proposed biosimilar PF-06438179 to the originator product as measured by the American College of Rheumatology 20 (ACR20) response at Week 14.
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 ↗ Comparable safety, immunogenicity and sustained efficacy were also demonstrated in patients who were switched from Remicade iii to FLIXABI, compared with those who continued on Remicade.
2016-05-30	Biogen	Regulatory FLIXABI®, Biogen’s Infliximab Biosimilar Referencing Remicade®, Approved in the European Union biogen.com ↗ The European Commission (EC) today granted marketing authorization in the European Union (EU) for FLIXABI ® , an infliximab biosimilar referencing Remicade ®i .
2016-05-23	Merck Sharp & Dohme LLC	Regulatory Merck Announces FDA Accepts Samsung Bioepis’ Biologics License Application (BLA) for SB2 (Infliximab), an Investigational Biosimilar of Remicade merck.com ↗ Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has accepted for review a Biologics License Application (BLA) submitted by Samsung Bioepis Co., Ltd. for SB2 (infliximab), an investigational biosimilar candidate of Remicade.
2016-04-06	Celltrion	Regulatory FDA approves Celltrion’s Inflectra(Infliximab-DYYB) for all eligible indications celltrion.com ↗ Celltrion, a global biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has approved INFLECTRA™ (infliximab-dyyb), which is sold in Europe as Remsima®, for all eligible indications of the reference product, Janssen Biotech Inc.'s Remicade® (infliximab)1 .
2016-04-05	Pfizer	Regulatory FDA Approves INFLECTRA™ (Biosimilar Infliximab), The First U.S. Biosimilar Monoclonal Antibody, For All Eligible Indications pfizer.com ↗ The United States (U.S.) Food and Drug Administration (FDA) today approved Celltrion’s INFLECTRA™ (biosimilar infliximab) across all eligible indications of the reference product, Remicade® (infliximab).
2016-04-01	Biogen	Regulatory FLIXABI®, an Infliximab Biosimilar Candidate Referencing Remicade®, Receives Positive CHMP Opinion biogen.com ↗ The Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for the marketing authorization of FLIXABI ® (infliximab).
2016-03-18	Celltrion	Results Switching to Remsima®▼ (infliximab) from originator has no negative effect on safety or efficacy in 10 real-world studies celltrion.com ↗ Real-world studies with nearly 600 inflammatory bowel disease (IBD) patients in eight countries show comparable efficacy and safety following a switch to biosimilar infliximab from originator infliximab.
2016-02-10	Celltrion	Regulatory FDA’s Arthritis Advisory Committee Recommends Approval of Celltrion’s CT-P13... celltrion.com ↗ Celltrion, a global biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) Arthritis Advisory Committee recommended approval of all eligible indications for CT-P13, a proposed biosimilar to Janssen Biotech Inc.'s Remicade® (infliximab), by a vote of 21-3.
2016-02-09	Pfizer	Regulatory Pfizer Commends The FDA Advisory Committee’s Vote To Approve Proposed Biosimilar Infliximab, The First Biosimilar Monoclonal Antibody Reviewed, For All Eligible Indications pfizer.com ↗ Pfizer Inc. commends today’s recommendation by the United States (U.S.) Food and Drug Administration’s (FDA) Arthritis Advisory Committee to approve the investigational biosimilar infliximab (CT-P13) across all eligible indications by a vote of 21 to three.
2015-12-07	Merck Sharp & Dohme LLC	Regulatory Merck Announces Samsung Bioepis Receives Approval of RENFLEXIS™ (Infliximab), a Biosimilar of Remicade, in Korea merck.com ↗ Samsung Bioepis Co., Ltd. has received approval of RENFLEXIS™ (infliximab), a biosimilar of the immunology medicine Remicade, by the Ministry of Food and Drug Safety (MFDS) in Korea.
2015-10-28	Celltrion	Results No difference in efficacy or immunogenicity following switch to Remsima®▼ (infliximab) from originator celltrion.com ↗ New clinical data indicate no differences in efficacy, adverse events and immunogenicity when patients with inflammatory bowel disease (IBD) are switched to the biosimilar infliximab Remsima® from originator infliximab (the reference medicinal product or RMP).
2015-06-10	Merck Sharp & Dohme LLC	Results Merck and Samsung Bioepis Announce Pivotal Phase 3 Studies for Investigational Biosimilars SB4, Enbrel (Etanercept), and SB2, Remicade (Infliximab), Met Primary Endpoints merck.com ↗ In these studies, SB4 and SB2 demonstrated a safety profile equivalent to the originator medicines.
2015-06-10	Celltrion	Results Time for a switch for patients with rheumatoid arthritis and ankylosing spondylitis celltrion.com ↗ Similar immunogenicity between biosimilar infliximab and the RMP in patients with RA and AS was also demonstrated in another study presented at EULAR 2015.
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 ↗
2015-05-19	Celltrion	Results Patients feel the benefit of biosimilar infliximab in Europe celltrion.com ↗ The clinical data from 46 Crohn’s disease (CD) and 32 ulcerative colitis (UC) patients presented at the meeting showed a statistically significant reduction in disease activity at week fourteen.
2015-02-20	Celltrion	Results Six posters on clinical experience with biosimilar mAb infliximab presented at European Crohn’s and Colitis Organisation (ECCO) 10th annual congress celltrion.com ↗ Data from six prospective observational trials, totalling 258 patients from Europe and South Korea, show that the biosimilar infliximab is an effective and well-tolerated treatment for patients with CD and UC.
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.
2014-08-11	Celltrion	Regulatory Celltrion files for US FDA approval of Remsima® celltrion.com ↗ Celltrion announced that the company, on August 8, 2014, completed the filing procedure to obtain US FDA approval for its infliximab biosimilar.
2014-07-16	Celltrion	Regulatory Celltrion’s ‘Remsima’ receives Turkey Ministry of Health approval celltrion.com ↗ Celltrion announced today that the Ministry of Health in Turkey (MoH) has granted marketing approval for RemsimaTM (infliximab).
2014-07-04	Celltrion	Regulatory Celltrion’s Remsima (infliximab) receives marketing approval in Japan celltrion.com ↗ Celltrion, Inc. (KOSDAQ: 068270) announced today that the company has received marketing authorization for its autoimmune disease treatment biosimilar mAb RemsimaTM (infliximab) from the Japan's Ministry of Health, Labour and Welfare (MHLW).
2013-10-31	Celltrion	Results Open-label extension of PLANETRA (additional one year), crossover study result support Remsima celltrion.com ↗ The study result demonstrated that patients being administered with infliximab and switching to CT-P13 (Remsima, Inflectra) showed no differences in efficacy or side-effects, which attracted the attention of rheumatologist attendees from all over the world.
2013-09-11	Celltrion	Regulatory Celltrion completes filing procedure for approval of Remsima in Japan celltrion.com ↗ Celltrion (KOSDAQ: 068270) announced today that the company has completed filing procedure of Remsima (Project code: CT-P13) to obtain Japan's Ministry of Health, Labour and Welfare (MHLW) approval.
2013-07-29	Celltrion	Regulatory Celltrion’s Remsima (infliximab) receives positive opinion from EMA’s CHMP celltrion.com ↗ Celltrion announced on June 28, 2013 that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) had given positive opinion for Celltrion-developed Remsima™ for sale in the European Union (EU).
2013-06-16	Celltrion	Results Remsima extended clinical trial study result was disclosed in EULAR 2013 celltrion.com ↗ According to these study result, RemsimaTM demonstrated clinical comparability to its original reference product in the week 14, week 30, and week 54 stages through all categories, including efficacy and safety profiles, and did not show any clinical difference.
2012-05-08	Tanabe Pharma Corporation	Regulatory Remicade® for I.V. Infusion 100, Anti-Human TNF α Monoclonal Antibody A New Option to Shorten Infusion Time tanabe-pharma.com ↗ Mitsubishi Tanabe Pharma Corporation (President & CEO: Michihiro Tsuchiya) announced today that a label extension for the anti-human TNF α monoclonal antibody, Remicade ® for I.V. Infusion 100 (generic name: infliximab) allows a shortened infusion time in carefully selected patients treated with Remicade ®, from their fourth infusion.
2012-05-08	Tanabe Pharma Corporation	Regulatory Remicade® for I.V. Infusion 100, Anti-Human TNF α Monoclonal Antibody Lifting of Condition on Approval for Psoriasis tanabe-pharma.com ↗ Mitsubishi Tanabe Pharma Corporation (President & CEO: Michihiro Tsuchiya) announced today that the condition on approval for psoriasis of the anti-human TNF α monoclonal antibody, Remicade ® for I.V. Infusion 100 (generic name: infliximab) has been lifted.
2011-08-17	Tanabe Pharma Corporation	Regulatory Remicade® for I.V. Infusion 100, Anti-Human TNF α Monoclonal-Antibody Approval for a Partial Change of Dosage and Usage in Crohn’s Disease tanabe-pharma.com ↗ Mitsubishi Tanabe Pharma Corporation (President & CEO: Michihiro Tsuchiya) announced today that the Company has received, as of August 17, 2011, approval for a partial change of dosage and usage in Crohn's disease for an anti-human TNF-α monoclonal-antibody, Remicade® for I.V. Infusion 100 (generic name: infliximab).
2010-08-18	Tanabe Pharma Corporation	Regulatory Completes Post-Marketing Surveillance on All Patients with Refractory Uveoretinitis in Behcet's Disease REMICADE® I.V. Drip Infusion Anti-TNFα Monoclonal Antibody 100 tanabe-pharma.com ↗ The results of the surveillance were examined by the First Committee on New Drugs of the Pharmaceutical Affairs and Food Sanitation Council; and the condition imposed on approval was lifted.
2010-06-18	Tanabe Pharma Corporation	Regulatory Approval for Additional Indication of Ulcerative Colitis for Remicade® I.V. Drip Infusion 100, Anti-Human TNF α Monoclonal-Antibody tanabe-pharma.com ↗ Mitsubishi Tanabe Pharma Corporation (President & CEO: Michihiro Tsuchiya) announced today that the Company has received, as of June 18, 2010, approval for the additional indication of ulcerative colitis for Remicade® I.V. Drip Infusion 100 (generic name: infliximab), anti-human TNF-α monoclonal-antibody.
2010-01-20	Tanabe Pharma Corporation	Regulatory Approval for Additional Indication of Psoriasis for Remicade® I.V. Drip Infusion 100, Anti-Human TNF-α Monoclonal-Antibody tanabe-pharma.com ↗

All press releases naming this drug 107 releases

Date	Issuer	Release
Show all 107 releases opens the full record — a long page

Evidence & citations 31 cited values

Every value below carries the sentence it was read from. 366 sources stand behind the page.

Field	Value	Cited text
Known as	infliximab	“The BAT in this study was identified by the investigator prior to patient randomization among the following treatments currently used in this setting: anti-thymocyte globulin...” NCT02913261 ↗ 323 “The BAT in this study will freely be identified by the Investigator prior to patient randomization and may include treatments such as: anti-thymocyte globulin (ATG),...” NCT04118556 ↗ “Infliximab: Induction with 5 mg/kg intravenous (IV) at day 0, and 5 mg/kg IV at week 2; maintenance with 5 mg/kg IV at week 6, week 10 or week 14 and every eight weeks...” NCT05169593 ↗ “To be given subcutaneously via a prefilled syringe/autoinjector (etanercept, adalimumab, certolizumab pegol, golimumab) or intravenously via infusion (infliximab) at increasing...” NCT05115903 ↗ “Patients randomized to top-down arm will receive an induction regimen of three consecutive i.v. infusions of infliximab (Remicade, 5 mg/kg) at weeks 0, 2, and 6 plus AZA (2...” NCT01752790 ↗ “In severe refractory sarcoidosis not responding to conventional immunosuppressive treatment, the third-line tumor necrosis factor (TNF)-alpha inhibitor infliximab is an alternative.” NCT05689879 ↗ “TNF-a inhibitors: Etanercept (Enbrel, Benapali), Infliximab (Remicade, Inflectra, Flixabi), Adalimumab (Humira, Imraldi, AMGEVITA), Certolizumabpegol (Cimzia), Golimumab (Simponi)” NCT04378621 ↗ “The infliximab biosimilar CT-P13 was approved for use in Crohn's disease after clinical comparison with originator infliximab in ankylosing spondylitis and rheumatoid arthritis” PMID 30929895 ↗ Mar 2019 “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 ↗ “A randomized study comparing the pharmacokinetics of the potential biosimilar PF-06438179/GP1111 with Remicade® (infliximab) in healthy subjects (REFLECTIONS B537-01).” PMID 29504427 ↗ Mar 2018 “The purpose of this study is to improve the investigators understanding of the relationship between Crohn's disease and blood levels of the drug infliximab (Remicade).” NCT01438151 ↗ Show 313 more sources
Known as	anbaite	“The TNF-α antagonist (infliximab) used by the experimenter was manufactured by Hisun Biopharmaceuticals Ltd. under the trade name "anbaite".” NCT07176754 ↗
Known as	Avsola	“Remicade, Inflectra, Renflexis, Avsola, Humira, Amgevita, Hulio, Hadlima, Hyrimoz, Idacio” NCT05781152 ↗
Known as	CMAB008	“The Study of Infliximab (CMAB008 and Remicade) in Healthy Subjects to Compare the PK and Safety” NCT04779892 ↗
Known as	CP-P13	“Infliximab(Remicade or CP-P13)” NCT01571219 ↗
Known as	CT-P13	“An Open-Label, Single-Arm, Extension Study to Demonstrate Long-Term Efficacy and Safety of CT-P13 in Patients With Ankylosing Spondylitis Who Were Treated With Infliximab...” NCT01571206 ↗ 12 “The NOR-SWITCH main and extension trials demonstrated that switching from originator to biosimilar infliximab (CT-P13) is efficacious and safe across six diseases.” PMID 32965617 ↗ Oct 2020 “CT-P13 subcutaneous (SC), an SC formulation of the intravenous (IV) infliximab biosimilar CT-P13 IV, creates a unique exposure profile.” PMID 38788861 ↗ May 2024 “Infliximab (CT-P13, RemsimaTM) is intravenously administered at a dose of 5 mg/kg at week 0, 2, 6, 14, 22, 30, 38, and 46.” NCT06051253 ↗ “CT-P13 (Remsima®, Inflectra®) is a biosimilar of the infliximab reference product (RP; Remicade®).” PMID 27038608 ↗ Apr 2016 “CT-P13 (Infliximab) is a monoclonal antibody currently being developed by CELLTRION, Inc.” NCT01571219 ↗ NCT06738719 ↗ NCT02883452 ↗ NCT06274294 ↗ NCT02096861 ↗ NCT03446976 ↗ Show 2 more sources
Known as	CT-P13 SC	“Subcutaneous Infliximab (CT-P13 SC) as Maintenance Therapy for Crohn's disease and ulcerative colitis: 2-year results from open-label extensions of two randomized controlled...” PMID 40243842 ↗ Jun 2025
Known as	EU-INF	“between SB2 and EU-sourced INF (EU-INF), between SB2 and US-sourced INF (US-INF), and between EU-INF and US-INF” PMID 26577771 ↗ Dec 2015
Known as	IFX	“This Phase IIIb, randomized, multi-national, multi-center, blinded study of Infliximab (IFX) in subjects aged 18 and older with active RA is being conducted to assess whether...” NCT00394589 ↗ 18 “One of the most effective therapies to treat patients with moderate to severe disease is the antitumor necrosis factor (TNF) agent infliximab (IFX) either as monotherapy or as...” NCT04835506 ↗ “The purpose of the study is to compare the effects of methotrexate (MTX) alone or in combination with intravenous (IV) methylprednisolone (MP) or infliximab (IFX) on...” NCT00396747 ↗ “Eligible patients were randomly assigned to receive infliximab (IFX) and azathioprine (AZA) with a 7-day steroid tapering scheme (IFX+AZA arm) or AZA and conventional...” PMID 39586616 ↗ Jan 2025 “Ulcerative colitis patients treated with Infliximab (IFX) in deep remission after at least 12 months of treatment will be randomized to continue IFX or to stop IFX and start...” NCT03151525 ↗ “Infliximab (IFX), a monoclonal chimeric antibody against tumour necrosis factor (TNF) α, is effective for induction and maintenance of remission in moderate to severe Crohn's disease.” PMID 25524543 ↗ Dec 2014 “The purpose of this study is to determine whether a top-down treatment approach, prescribing infliximab (IFX) and azathioprine (AZA) at diagnose, yields better outcome” NCT02517684 ↗ “In nine refractory CD patients (7 infliximab [IFX] non-responders, 2 FMT non-responders), IFX-FMT combination led to week-4 response in 6 patients” PMID 41870087 ↗ Mar 2026 “The tumor necrosis factor-alpha (TNF-alpha) inhibitor infliximab (IFX) has been proven effective for the treatment of ankylosing spondylitis (AS).” PMID 20231198 ↗ Mar 2010 “Infliximab (IFX) is a Food and Drug administration (FDA)-appoved monoclonal antibody medication targeting tumor necrosis factor (TNF)” NCT06758024 ↗ “Loss of response (LOR) to infliximab (IFX) remains a challenge in the management of inflammatory bowel diseases (IBD).” PMID 33290108 ↗ Dec 2020 Show 8 more sources
Known as	IIFX	“Infliximab with azathioprine (IIFX + AZA)” NCT01559142 ↗
Known as	INF	“Infliximab (INF) + MTX, DB” NCT00095147 ↗
Known as	Inflectra	“The investigational medicinal product is infliximab (Inflectra®, Hospira, or any of the other biosimilars of IFX according to the local availability in the participating...” NCT05552287 ↗ 5 “Infliximab-Biosimilar (Inflectra) (5mg/kg or 10mg/kg) by intravenous (IV) infusion administered as a 2-hour infusion per dose as treatment.” NCT02452151 ↗ “Infliximab (Inflectra® \[Pfizer\]), dosage determined using model-informed precision dosing, intravenously administered” NCT04982172 ↗ “switching from the infliximab reference product (RP; Remicade) to its biosimilar CT-P13 (Remsima, Inflectra)” PMID 27130908 ↗ Apr 2016 “CT-P13 (Remsima®, Inflectra®) is a biosimilar of the infliximab reference product (RP; Remicade®).” PMID 27038608 ↗ Apr 2016 “Remicade, Inflectra, Renflexis, Avsola, Humira, Amgevita, Hulio, Hadlima, Hyrimoz, Idacio” NCT05781152 ↗
Known as	Infliximab (generic)	“Infliximab (generic)” NCT01971814 ↗
Known as	Infliximab - REMICADE as brand name	“Infliximab - REMICADE as brand name” NCT01361542 ↗
Known as	Infliximab-dyyb	ClinicalTrials.gov intervention name — accepted as the source's own label NCT05663268 ↗ 2 NCT06064864 ↗ NCT06591273 ↗
Known as	INX	“To compare the efficacy and safety of innovator infliximab (INX) and CT-P13, an INX biosimilar, in active rheumatoid arthritis patients with inadequate response to methotrexate...” PMID 23687260 ↗ May 2013
Known as	Remicade	“The purpose of this study is to evaluate the effectiveness and safety of infliximab, the active ingredient in Remicade, for the treatment of cachexia in pancreatic cancer...” NCT00060502 ↗ 60 “An Open-Label, Single-Arm, Extension Study to Demonstrate Long-Term Efficacy and Safety of CT-P13 in Patients With Ankylosing Spondylitis Who Were Treated With Infliximab...” NCT01571206 ↗ “A Multicenter Trial Comparing REMICADE (Infliximab) and Placebo in the Prevention of Recurrence in Crohn's Disease (CD) Patients Undergoing Surgical Resection Who Are at an...” NCT01190839 ↗ “BACKGROUND: CT-P13 (Remsima®, Inflectra®) is a biosimilar of the infliximab reference product (RP; Remicade®) and is approved in Europe and elsewhere, mostly for the same...” PMID 26795209 ↗ Jan 2016 “A Multicenter, Open-label Study to Assess the Efficacy and Safety of Infliximab (REMICADE�) Therapy in Patients With Plaque Psoriasis Who Had an Inadequate Response to...” NCT00527072 ↗ “Value of infliximab (Remicade®) in patients with low-risk myelodysplastic syndrome: final results of a randomized phase II trial (EORTC trial 06023) of the EORTC Leukemia Group.” PMID 22102701 ↗ Nov 2011 “Infliximab (Remicade) targets specific proteins in the body's immune system to help control the development of inflammation to help reduce the pain of rheumatoid arthritis.” NCT00036387 ↗ “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 ↗ “The purpose of this study is to improve the investigators understanding of the relationship between Crohn's disease and blood levels of the drug infliximab (Remicade).” NCT01438151 ↗ “The purpose of the study is to evaluate the effectiveness and safety of infliximab (Remicade) in children with moderately to severely active ulcerative colitis.” NCT00336492 ↗ “The purpose of this study is to evaluate the safety and effectiveness of infliximab (Remicade) in patients with Chronic Obstructive Pulmonary Disease (COPD).” NCT00056264 ↗ Show 50 more sources
Known as	Remicade (Registered Trademark)	“This study will determine whether a stepwise increase of the drug infliximab (Remicade® (Registered Trademark)) controls juvenile rheumatoid arthritis more effectively than a...” NCT00029042 ↗ 1 “This small, preliminary study will examine whether multiple infusions of infliximab (Remicade® (Registered Trademark)) can control inflammation in patients with active scleritis.” NCT00075075 ↗
Known as	Remicade, SCH 215596	“Remicade, SCH 215596” NCT01148901 ↗
Known as	RemicadeTM	“Chimeric A2 (infliximab, RemicadeTM) IgG” NCT00604864 ↗
Known as	Remicaide	“Remicaide (infliximab)” NCT00372723 ↗
Known as	Remsima	“There are no clinical trials with Remsima® 120 mg given subcutaneously without IV loading doses of CT-P13 in patients with IBD.” NCT06274294 ↗ 4 “switching from the infliximab reference product (RP; Remicade) to its biosimilar CT-P13 (Remsima, Inflectra)” PMID 27130908 ↗ Apr 2016 “CT-P13 (Remsima®, Inflectra®) is a biosimilar of the infliximab reference product (RP; Remicade®).” PMID 27038608 ↗ Apr 2016 “Efficacy and Safety of Infliximab Biosimilar Remsima in Psoriasis” NCT06043752 ↗ “Infliximab-dyyb Biosimilar (Remsima)” NCT06591273 ↗
Known as	Remsima (infliximab-dyyb biosimilar)	“Remsima (infliximab-dyyb biosimilar)” NCT05663268 ↗
Known as	RemsimaTM	“Infliximab (CT-P13, RemsimaTM) is intravenously administered at a dose of 5 mg/kg at week 0, 2, 6, 14, 22, 30, 38, and 46.” NCT06051253 ↗
Known as	SB2	“Three Formulations of Infliximab (SB2, EU Sourced Remicade® and US Sourced Remicade®) in Healthy Subjects” NCT01922336 ↗
Known as	TA-650	ClinicalTrials.gov intervention name — accepted as the source's own label NCT01596335 ↗ 6 NCT00691028 ↗ NCT01680159 ↗ NCT01585155 ↗ NCT01580670 ↗ NCT00805766 ↗ NCT01532570 ↗
Known as	US-INF	“between SB2 and EU-sourced INF (EU-INF), between SB2 and US-sourced INF (US-INF), and between EU-INF and US-INF” PMID 26577771 ↗ Dec 2015
Action	Inhibit	“anti-TNF-alpha antibody” NCT00006292 ↗
Modality	Monoclonal antibody	“The anti-TNF-alpha monoclonal antibody infliximab” NCT00006292 ↗
Route	Intravenous	“The drug is given intravenously (IV, into a vein)” NCT00029042 ↗
Target	TNF	“a chimeric IgG(1) kappa monoclonal antibody against TNF” NCT00033891 ↗