Drugs / Golimumab
Golimumab
also known as
Simponi · CNTO 148 · GOL · GLM · Drug: Golimumab (Simponi) · MK-8259 · Ref-GLM · SCH 900259
Monoclonal antibody targets TNF via inhibition
Regulatory milestones approvals, filings & regulatory actions · 12 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed juvenile ankylosing spondylitis 1 milestone | |||||
| Filed | US (FDA) | SIMPONI ARIA | juvenile ankylosing spondylitis | 2020-04-24 | “submission of two supplemental Biologics License Applications (sBLA) to the U.S. Food and Drug Administration (FDA) seeking approval of SIMPONI ARIA®(golimumab)” jnj.com ↗ “Regulatory Submissions SIMPONI ARIA (golimumab) – Submission to the U.S. Food and Drug Administration (FDA)” jnj.com ↗ |
| Filed polyarticular juvenile idiopathic arthritis 1 milestone | |||||
| Filed | US (FDA) | SIMPONI ARIA | polyarticular juvenile idiopathic arthritis | 2020-04-24 | “submission of two supplemental Biologics License Applications (sBLA) to the U.S. Food and Drug Administration (FDA) seeking approval of SIMPONI ARIA®(golimumab)” jnj.com ↗ “Regulatory Submissions SIMPONI ARIA (golimumab) – Submission to the U.S. Food and Drug Administration (FDA)” jnj.com ↗ |
| Approved Indication not stated 4 milestones | |||||
| Label expansions (4) | US (FDA) | SIMPONI | — | 2013-05-15 – 2025-10-07 | fda.gov ↗ |
| Label expansions (4) | US (FDA) | SIMPONI ARIA | — | 2015-08-05 – 2021-02-01 | fda.gov ↗ |
| Approved | EU (EMA) | Simponi | — | 2009-10-01 | europa.eu ↗ |
| Approved | US (FDA) | SIMPONI | — | 2009-04-24 | fda.gov ↗ |
Trials 84 · started per year
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EU approved 2009
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| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial · 1 missed | ||||||
| Phase 0 | NCT03632759 | Aug 2018 → Nov 2021 | type 1 diabetes mellitus | Carla Greenbaum, MD | Completed | Missed primary |
| Phase 15 trials | ||||||
| Phase 1 | NCT03298542 | Oct 2017 → Dec 2020 | type 1 diabetes mellitus | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 1 | NCT01900574 | Aug 2013 → Feb 2015 | ulcerative colitis | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 1 | NCT01258777 | Oct 2010 → Apr 2011 | — | Centocor, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT01288157 | Sep 2010 → Jan 2011 | — | Centocor, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT01362153 | Dec 2007 → Feb 2009 | rheumatoid arthritis | Centocor, Inc. | Completed | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT01526174 | Mar 2012 → Dec 2013 | autoimmune inner ear disease | House Research Institute | Terminated | No outcome recorded |
| Phase 218 trials · 2 met primary · 3 missed | ||||||
| Phase 2 | NCT07683026 | Aug 2026 → Sep 2032 expected | type 1 diabetes mellitus | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | 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 | NCT05960578 | May 2024 → Jul 2025 overdue | prostate adenocarcinoma | University of Washington | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05242484 | Sep 2022 → May 2025 overdue | ulcerative colitis | Janssen Research & Development, LLC | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05242471 | Jul 2022 → May 2025 overdue | Crohn disease | Janssen Research & Development, LLC | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05071664 | Oct 2021 → May 2024 | psoriatic arthritis | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 2 | NCT04729296 | Jul 2021 → Jul 2027 | type 1 diabetes mellitus | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | Withdrawn | No outcome recorded |
| Phase 2 | NCT04218565 | Feb 2020 → Dec 2022 | Behcet disease, uveitis | Wenjie Zheng | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT03662542 | Nov 2018 → Dec 2020 | ulcerative colitis | Janssen Research & Development, LLC | Completed | Mixed |
| Phase 2 | NCT03182166 | Nov 2017 → Jun 2021 | ulcerative colitis | University Hospital of Saint-Etienne | Completed | No outcome recorded |
| Phase 2 | NCT02846545 | Aug 2016 → May 2019 | type 1 diabetes mellitus | Janssen Research & Development, LLC | Completed | Met primary |
| Phase 2 | NCT01988961 | Dec 2013 → Feb 2015 | ulcerative colitis | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 2 | NCT01715896 | Mar 2013 → Nov 2014 | rheumatoid arthritis | MedImmune LLC | Completed | Missed primary |
| Phase 2 | NCT02456363 | Nov 2009 → Oct 2019 | ankylosing spondylitis | Chung Shan Medical University | Unknown | No outcome recorded |
| Phase 2 | NCT00955279 | Nov 2009 → May 2012 | sarcoidosis | Centocor, Inc. | Completed | Missed primary |
| Phase 2 | NCT00675649 | May 2008 → ? | asthma | Centocor, Inc. | Withdrawn | No outcome recorded |
| Phase 2 | NCT00207740 | Aug 2004 → Jul 2007 | asthma | Centocor, Inc. | Completed | Missed primary |
| Phase 2 | NCT00207714 | Nov 2003 → Feb 2005 | rheumatoid arthritis | Centocor, Inc. | Completed | Met primary |
| Phase 2/32 trials · 1 met primary · 1 missed | ||||||
| Phase 2/3 | NCT00487539 | Aug 2007 → Oct 2010 | ulcerative colitis | Janssen Research & Development, LLC | Completed | Met primary |
| Phase 2/3 | NCT00488774 | Aug 2007 → May 2009 | ulcerative colitis | Janssen Research & Development, LLC | Terminated | Missed primary |
| Phase 330 trials · 16 met primary · 3 missed | ||||||
| Phase 3 | NCT05379322 | Mar 2023 | rheumatoid arthritis | Abu Dhabi Stem Cells Center | Withdrawn | 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 | NCT03596645 | Oct 2018 → Nov 2023 overdue | ulcerative colitis | Janssen Research & Development, LLC | Active not recruiting | Met primary |
| Phase 3 | NCT03270501 | Nov 2017 → Dec 2023 | spondyloarthropathy | University Ghent | Completed | No outcome recorded |
| Phase 3 | NCT04108468 | Oct 2015 → Jul 2023 | psoriatic arthritis | The Leeds Teaching Hospitals NHS Trust | Completed | Missed primary |
| Phase 3 | NCT02277444 | Dec 2014 → Jul 2018 | polyarticular juvenile idiopathic arthritis | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 3 | NCT02181673 | Sep 2014 → May 2016 | psoriatic arthritis | Janssen Research & Development, LLC | Completed | Met primary |
| Phase 3 | NCT02186873 | Sep 2014 → Dec 2015 | ankylosing spondylitis | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 3 | NCT02065713 | Aug 2014 → Jun 2017 | psoriatic arthritis | Gulbenkian Institute for Molecular Medicine | Completed | Met primary |
| Phase 3 | NCT01962974 | Oct 2013 → Dec 2014 | rheumatoid arthritis | Janssen Biotech, Inc. | Terminated | No outcome recorded Stop: Enrollment |
| Phase 3 | NCT01871649 | Aug 2013 → Nov 2018 | psoriatic arthritis | Academic Medical Center - University of Amsterdam | Completed | Met primary |
| Phase 3 | NCT01863771 | Mar 2013 → Jan 2016 | ulcerative colitis | Janssen Pharmaceutical K.K. | Completed | No outcome recorded |
| Phase 3 | NCT01426815 | Mar 2012 → Mar 2019 | spondyloarthropathy | University Hospital, Ghent | Completed | Met primary |
| Phase 3 | NCT01453725 | Feb 2012 → Mar 2014 | ankylosing spondylitis | Merck Sharp & Dohme LLC | Completed | Met primary |
| Phase 3 | NCT01230827 | Dec 2010 → Sep 2013 | juvenile idiopathic arthritis | Janssen Research & Development, LLC | Terminated | Missed primary |
| Phase 3 | NCT01248793 | Oct 2010 → May 2011 | ankylosing spondylitis | Centocor, Inc. | Completed | Met primary |
| Phase 3 | NCT01248780 | Sep 2010 → Oct 2011 | rheumatoid arthritis | Centocor, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT01004432 | Dec 2009 → Jul 2013 | rheumatoid arthritis | Janssen Biotech, Inc. | Completed | Met primary |
| Phase 3 | NCT00975130 | Sep 2009 → Aug 2011 | rheumatoid arthritis | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 3 | NCT00973479 | Sep 2009 → Mar 2011 | rheumatoid arthritis | Centocor, Inc. | Completed | Met primary |
| Phase 3 | NCT02779114 | Jan 2009 → Dec 2017 | rheumatoid arthritis | University of Erlangen-Nürnberg Medical School | Unknown | No outcome recorded |
| Phase 3 | NCT00727987 | May 2008 → Dec 2011 | rheumatoid arthritis | Janssen Pharmaceutical K.K. | Completed | Met primary |
| Phase 3 | NCT00771251 | May 2008 → Oct 2011 | rheumatoid arthritis | Janssen Pharmaceutical K.K. | Completed | Met primary |
| Phase 3 | NCT00488631 | Sep 2007 → Oct 2011 | ulcerative colitis | Janssen Research & Development, LLC | Completed | Met primary |
| Phase 3 | NCT00361335 | Sep 2006 → Dec 2007 | rheumatoid arthritis | Centocor, Inc. | Completed | Missed primary |
| Phase 3 | NCT00299546 | Feb 2006 → Aug 2007 | rheumatoid arthritis | Centocor, Inc. | Completed | Met primary |
| Phase 3 | NCT00265083 | Dec 2005 → Mar 2007 | ankylosing spondylitis | Centocor, Inc. | Completed | Met primary |
| Phase 3 | NCT00265096 | Dec 2005 → May 2007 | psoriatic arthritis | Centocor, Inc. | Completed | Met primary |
| Phase 3 | NCT00264550 | Dec 2005 → Sep 2007 | rheumatoid arthritis | Centocor, Inc. | Completed | Met primary |
| Phase 3 | NCT00264537 | Dec 2005 → Apr 2008 | rheumatoid arthritis | Centocor, Inc. | Completed | Mixed |
| Phase 421 trials · 2 met primary | ||||||
| Phase 4 | NCT07149792 | Jul 2025 → Dec 2026 expected | psoriasis, psoriatic arthritis | Taichung Veterans General Hospital | Recruiting | No outcome recorded |
| Phase 4 | NCT05164198 | Jan 2022 → Oct 2024 | ankylosing spondylitis | Hanyang University Seoul Hospital | Unknown | 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 | NCT04156984 | Apr 2021 → Jun 2024 | ulcerative colitis | David Drobne | Completed | No outcome recorded |
| Phase 4 | NCT03733925 | Jan 2019 → Nov 2021 | ankylosing spondylitis, psoriatic arthritis | Johnson & Johnson Private Limited | Completed | No outcome recorded |
| Phase 4 | NCT03669029 | Oct 2018 → Dec 2019 | ulcerative colitis | Hospital de Manises | Unknown | No outcome recorded |
| Phase 4 | NCT03253796 | Nov 2017 → Mar 2021 | spondyloarthropathy | Merck Sharp & Dohme LLC | Completed | Met primary |
| Phase 4 | NCT03124121 | Sep 2017 → Sep 2019 | ulcerative colitis | Guy's and St Thomas' NHS Foundation Trust | Completed | No outcome recorded |
| Phase 4 | NCT02425865 | Dec 2016 → Oct 2021 | ulcerative colitis | Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives | Completed | No outcome recorded |
| Phase 4 | NCT02687724 | Jun 2016 → Feb 2020 | colitis | University College Dublin | Unknown | No outcome recorded |
| Phase 4 | NCT02714634 | Mar 2016 → Mar 2029 expected | rheumatoid arthritis | University Hospital, Strasbourg, France | Recruiting | No outcome recorded |
| Phase 4 | NCT02412085 | Mar 2015 → Dec 2016 | ulcerative colitis | Istituto Clinico Humanitas | Unknown | No outcome recorded |
| Phase 4 | NCT02318667 | Feb 2015 → Jun 2017 | ulcerative colitis | Merck Sharp & Dohme LLC | Completed | Mixed |
| Phase 4 | NCT02186886 | Jun 2014 → Dec 2015 | ulcerative colitis | Kliniken im Naturpark Altmuehltal | Unknown | No outcome recorded |
| Phase 4 | NCT02092285 | May 2014 → May 2016 | ulcerative colitis | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 4 | NCT01668004 | Sep 2012 → Apr 2015 | ankylosing spondylitis | Merck Sharp & Dohme LLC | Completed | Mixed |
| 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 | 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 not applicable5 trials | ||||||
| — | NCT05305066 | Feb 2023 → Dec 2028 expected | rheumatoid arthritis | Marie Hudson, MD | Recruiting | No outcome recorded |
| — | NCT04531423 | Oct 2020 → Sep 2022 | major depressive disorder | Shanghai Mental Health Center | Unknown | No outcome recorded |
| — | NCT04378621 | Oct 2020 → Sep 2025 | depressive disorder, rheumatoid arthritis, subjective cognitive decline | Vastra Gotaland Region | Unknown | No outcome recorded |
| — | NCT04156425 | Jul 2020 → Dec 2024 | major depressive disorder | Shanghai Mental Health Center | Unknown | No outcome recorded |
| — | NCT02841176 | Jul 2016 → Sep 2017 | psoriatic arthritis | Imperial College Healthcare NHS Trust | Terminated | No outcome recorded |
| Phase not stated1 trial | ||||||
| — | NCT03945903 | — | type 1 diabetes mellitus | Janssen Research & Development, LLC | No longer available | No outcome recorded |
| Comparator or background therapy23 trials | ||||||
| Phase 1 | NCT05632211 Comparator | Dec 2022 → Oct 2023 | — | Alvotech Swiss AG | Completed | Met primary |
| Phase 1 | NCT05332730 Comparator | Aug 2022 → Jun 2023 | psoriatic arthritis | Bio-Thera Solutions | Completed | No outcome recorded |
| Phase 2 | NCT02862574 Background | Dec 2016 → Jun 2017 | rheumatoid arthritis | Gilead Sciences | Terminated | No outcome recorded |
| Phase 2 | NCT01217814 Comparator | Nov 2010 → Sep 2011 | rheumatoid arthritis | Sanofi | Terminated | No outcome recorded |
| Phase 3 | NCT05669833 Comparator | Jul 2023 → Oct 2026 expected | psoriatic arthritis | University of Pennsylvania | Recruiting | No outcome recorded |
| Phase 3 | NCT05842213 Comparator | Mar 2023 → Mar 2024 | rheumatoid arthritis | Alvotech Swiss AG | Completed | Met primary |
| Phase 3 | NCT05046431 Comparator | May 2021 → Oct 2023 | psoriatic arthritis | Bio-Thera Solutions | Completed | Met primary |
| Phase 3 | NCT02437162 Background | Sep 2015 → Mar 2017 | spondyloarthropathy | Janssen Research & Development, LLC | Terminated | Missed primary |
| Phase 3 | NCT02438787 Background | Jul 2015 → Aug 2017 | spondyloarthropathy | Janssen Research & Development, LLC | Terminated | No outcome recorded |
| Phase 3 | NCT03414502 Comparator | Dec 2007 → Mar 2028 expected | rheumatoid arthritis | University of Nebraska | Recruiting | No outcome recorded |
| Phase 4 | NCT05313620 Comparator | Apr 2022 → Jun 2026 | ulcerative colitis, venous thromboembolism | Fundación de Investigación Biomédica - Hospital Universitario de La Princesa | Completed | No outcome recorded |
| Phase 4 | NCT03885713 Comparator | Sep 2019 → Dec 2024 | Crohn disease, ulcerative colitis | Fundación de Investigación Biomédica - Hospital Universitario de La Princesa | Completed | No outcome recorded |
| Phase 4 | NCT03445845 Comparator | Dec 2018 → Sep 2024 | spondyloarthropathy | University Hospital of Saint-Etienne | Completed | No outcome recorded |
| Phase 4 | NCT03100253 Comparator | Mar 2018 → Dec 2021 | rheumatoid arthritis | Mario Negri Institute for Pharmacological Research | Terminated | No outcome recorded |
| Phase 4 | NCT02758782 Comparator | Sep 2016 → Jan 2021 | ankylosing spondylitis | Charite University, Berlin, Germany | Completed | No outcome recorded |
| Phase 4 | NCT02242474 Comparator | Jul 2015 → Oct 2019 | rheumatoid arthritis | CHU de Quebec-Universite Laval | Unknown | No outcome recorded |
| Phase 4 | NCT02155335 Background | Jul 2014 → Oct 2015 | ulcerative colitis | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 4 | NCT02236481 Comparator | Jul 2013 → Dec 2017 | rheumatoid arthritis, type 2 diabetes mellitus | Prof. Roberto Giacomelli | Terminated | No outcome recorded |
| Phase 4 | NCT01804166 Background | Mar 2013 → Feb 2020 | hepatosplenic T-cell lymphoma | Janssen Scientific Affairs, LLC | Completed | No outcome recorded |
| Phase 4 | NCT01718951 Comparator | Aug 2012 → Mar 2014 | spondyloarthropathy | Tuen Mun Hospital | Completed | No outcome recorded |
| Phase 4 | NCT01212653 Comparator | Oct 2010 → May 2013 | ankylosing spondylitis | Chinese University of Hong Kong | Completed | No outcome recorded |
| — | NCT06896305 Background | May 2025 → Apr 2027 expected | Crohn disease, ulcerative colitis | IRCCS Ospedale San Raffaele | Recruiting | No outcome recorded |
| — | NCT01610947 Comparator | May 2012 → Oct 2018 | spondyloarthropathy | University Hospital, Montpellier | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 36
| Date | Issuer | Release |
|---|---|---|
| 2026-05-05 | Janssen Research & Development, LLC | Results Johnson & Johnson investigational co-antibody therapy JNJ-4804 shows potential to raise the bar for clinical efficacy in treating refractory inflammatory bowel disease jnj.com ↗
In the overall population, JNJ-4804ademonstrated higher clinical remissionbrates (50.8%) and endoscopic responsecrates (38.1%) versus golimumab (25.4% for clinical remission, 19.8% for endoscopic response) at Week 48. |
| 2026-05-05 | Janssen Research & Development, LLC | Results Johnson & Johnson investigational co-antibody therapy JNJ-4804 shows potential to raise the bar for clinical efficacy in treating refractory inflammatory bowel disease jnj.com ↗ |
| 2025-11-20 | Alvotech Swiss AG | Regulatory Alvotech and Advanz Pharma Receive Marketing Approval Across the European Economic Area for Gobivaz®, a First-in-Market Biosimilar to Simponi® (golimumab) alvotech.com ↗
Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide and Advanz Pharma Holdco Limited (“Advanz Pharma”), a UK headquartered global pharmaceutical company with a strategic focus on specialty, hospital, and rare disease medicines in Europe, today announced that the European Commission (EC) has granted marketing authorizations in the European Economic Area (EEA) for Gobivaz®, Alvotech’s biosimilar to Simponi® (golimumab). |
| 2025-11-20 | Advanz Pharma | Regulatory Alvotech and Advanz Pharma Receive Marketing Approval Across the European Economic Area for Gobivaz® a Biosimilar to Simponi® (golimumab) advanzpharma.com ↗
today announced that the European Commission (EC) has granted marketing authorizations in the European Economic Area (EEA) for Gobivaz®, Alvotech’s biosimilar to Simponi® (golimumab). |
| 2025-11-06 | Alvotech Swiss AG | Regulatory Alvotech and Advanz Pharma Receive Marketing Authorisations for Gobivaz®, a Biosimilar to Simponi® (golimumab), from the MHRA alvotech.com ↗ |
| 2025-11-06 | Advanz Pharma | Regulatory Alvotech and Advanz Pharma Receive Marketing Authorisations for Gobivaz®, a Biosimilar to Simponi® (golimumab), from the MHRA advanzpharma.com ↗ |
| 2025-10-07 | Janssen Research & Development, LLC | Regulatory U.S. FDA approves SIMPONI® (golimumab) for the treatment of pediatric ulcerative colitis jnj.com ↗
Johnson & Johnson today announced that the U.S. Food and Drug Administration (FDA) has approved SIMPONI® (golimumab) for the treatment of children living with moderately to severely active ulcerative colitis (UC), weighing at least 15 kg. |
| 2025-09-22 | Alvotech Swiss AG | Regulatory European Medicines Agency Recommends Marketing Approval of Gobivaz®, Alvotech’s Proposed Biosimilar to Simponi® (golimumab) with Advanz Pharma as Commercialization Partner alvotech.com ↗
The positive CHMP opinion for Gobivaz® is an important milestone in expanding patient access and marks a significant step forward in Advanz Pharma’s ambition to build a leading biosimilars presence in Europe. |
| 2025-09-22 | Advanz Pharma | Regulatory European Medicines Agency Recommends Marketing Approval of Gobivaz®, Alvotech’s Proposed Biosimilar to Simponi® (golimumab) with Advanz Pharma as Commercialization Partner advanzpharma.com ↗
today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human use (CHMP) adopted a positive opinion recommending approval for Gobivaz®, Alvotech’s proposed biosimilar to Simponi® (golimumab), a biologic used to treat several chronic inflammatory diseases. |
| 2025-09-19 | Alvotech Swiss AG | Regulatory Alvotech Announces Marketing Approval in Japan of Three New Biosimilars alvotech.com ↗
AVT05, approved in Japan as GOLIMUMAB BS 50 mg PFS for subcutaneous injection, is a biosimilar to Simponi® (golimumab). |
| 2025-01-27 | Alvotech Swiss AG | Regulatory Alvotech and Teva Announce Filing Acceptance of U.S. Biologics License Applications for AVT05, a Proposed Biosimilar to Simponi® and Simponi Aria® (golimumab) alvotech.com ↗
These are the first U.S. BLA filing acceptances announced for a biosimilar candidate to golimumab. |
| 2025-01-27 | Teva Branded Pharmaceutical Products R&D, Inc. | Regulatory Alvotech and Teva Announce Filing Acceptance of U.S. Biologics License Applications for AVT05, a Proposed Biosimilar to Simponi® and Simponi Aria® (golimumab) tevapharm.com ↗
These are the first U.S. BLA filing acceptances announced for a biosimilar candidate to golimumab. |
| 2024-12-16 | Janssen Research & Development, LLC | Regulatory Johnson & Johnson submits application seeking U.S. FDA approval of SIMPONI® (golimumab) for the treatment of pediatric ulcerative colitis jnj.com ↗
HORHSAM, Pa. (December 16, 2024)–Johnson & Johnson today announced the submission of a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) seeking expanded approval of SIMPONI®(golimumab) for the treatment of children two years and older with moderately to severely active ulcerative colitis (UC). |
| 2024-11-13 | Alvotech Swiss AG | Regulatory Alvotech Reports Financial Results for the First Nine Months of 2024 alvotech.com ↗
Alvotech announced that the European Medicines Agency (EMA) accepted a Marketing Authorization Application (MAA) for AVT03, a proposed biosimilar to Prolia® and Xgeva® (denosumab) and an MAA for AVT05, a proposed biosimilar to Simponi® (golimumab). |
| 2024-11-07 | Janssen Research & Development, LLC | Results Johnson & Johnson advances leadership in rheumatic disease innovation with 43 abstracts at ACR 2024 jnj.com ↗
Guselkumab and Golimumab Combination Induction Therapy in Ulcerative Colitis Results in Early Local Tissue Healing That is Sustained Through Guselkumab Maintenance Therapy |
| 2024-11-07 | Janssen Research & Development, LLC | Results Johnson & Johnson advances leadership in rheumatic disease innovation with 43 abstracts at ACR 2024 jnj.com ↗
Guselkumab and Golimumab Combination Induction Therapy in Ulcerative Colitis Results in Early Local Tissue Healing That is Sustained Through Guselkumab Maintenance Therapy |
| 2024-11-04 | Alvotech Swiss AG | Regulatory European Medicines Agency Confirms Acceptance of Marketing Authorization Application for AVT05, a Proposed Biosimilar to Simponi® (golimumab) alvotech.com ↗
Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide and Advanz Pharma, a UK headquartered global pharmaceutical company with a strategic focus on specialty, hospital, and rare disease medicines in Europe, today announced that the European Medicines Agency (EMA) has accepted a Marketing Authorization Application for AVT05, Alvotech’s proposed biosimilar to Simponi® (golimumab), a biologic used to treat several chronic inflammatory diseases. |
| 2024-11-04 | Advanz Pharma | Regulatory European Medicines Agency Confirms Acceptance of Marketing Authorization Application for AVT05, a Proposed Biosimilar to Simponi® (golimumab) advanzpharma.com ↗
Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide and ADVANZ PHARMA, a UK headquartered global pharmaceutical company with a strategic focus on specialty, hospital, and rare disease medicines in Europe, today announced that the European Medicines Agency (EMA) has accepted a Marketing Authorization Application for AVT05, Alvotech’s proposed biosimilar to Simponi® (golimumab), a biologic used to treat several chronic inflammatory diseases. |
| 2022-10-10 | Janssen Research & Development, LLC | Results Results of Novel Clinical Study of Guselkumab and Golimumab Combination Therapy Show Adults with Moderately to Severely Active Ulcerative Colitis Maintained Higher Rates of Clinical, Histologic, and Endoscopic Remission at Week 38 jnj.com ↗ |
| 2022-10-10 | Janssen Research & Development, LLC | Results Results of Novel Clinical Study of Guselkumab and Golimumab Combination Therapy Show Adults with Moderately to Severely Active Ulcerative Colitis Maintained Higher Rates of Clinical, Histologic, and Endoscopic Remission at Week 38 jnj.com ↗
The rate of clinical remission was 47.9 percent in patients who received combination induction therapy with guselkumab and golimumab compared with either treatment alone (31.0 percent and 20.8 percent, respectively) at 38 weeks1 |
| 2022-02-19 | Janssen Research & Development, LLC | Results Results of Novel Clinical Study Show Adults with Moderately to Severely Active Ulcerative Colitis Achieved Higher Rates of Clinical Response, Clinical Remission, and Endoscopic Improvement at 12 Weeks with Guselkumab and Golimumab Combination Therapy Versus Either Monotherapy Alone jnj.com ↗
The VEGA Phase 2a proof-of-concept study shows 83.1 percent of patients who received combination therapy achieved the primary endpoint of clinical response and 36.6 percent of patients achieved clinical remission at week 12 |
| 2020-09-30 | Janssen Research & Development, LLC | Regulatory SIMPONI ARIA® (golimumab) Approved by the U.S. Food and Drug Administration for Active Polyarticular Juvenile Idiopathic Arthritis and Extension of Its Active Psoriatic Arthritis Indication in Patients 2 Years of Age and Older jnj.com ↗ |
| 2020-09-30 | Janssen Research & Development, LLC | Regulatory SIMPONI ARIA® (golimumab) Approved by the U.S. Food and Drug Administration for Active Polyarticular Juvenile Idiopathic Arthritis and Extension of Its Active Psoriatic Arthritis Indication in Patients 2 Years of Age and Older jnj.com ↗ |
| 2020-04-24 | Janssen Research & Development, LLC | Regulatory Janssen Announces Submission of Two Applications to U.S. FDA Seeking Approval of SIMPONI ARIA® (golimumab) for the Treatment of Polyarticular Juvenile Idiopathic Arthritis and Juvenile Psoriatic Arthritis jnj.com ↗
The Janssen Pharmaceutical Companies of Johnson & Johnson today announced the submission of two supplemental Biologics License Applications (sBLA) to the U.S. Food and Drug Administration (FDA) seeking approval of SIMPONI ARIA®(golimumab) for the treatment of polyarticular juvenile idiopathic arthritis (pJIA) and juvenile psoriatic arthritis (jPsA), in patients two years of age and older in combination with methotrexate. |
| 2020-04-24 | Janssen Research & Development, LLC | Regulatory Janssen Announces Submission of Two Applications to U.S. FDA Seeking Approval of SIMPONI ARIA® (golimumab) for the Treatment of Polyarticular Juvenile Idiopathic Arthritis and Juvenile Psoriatic Arthritis jnj.com ↗
today announced the submission of two supplemental Biologics License Applications (sBLA) to the U.S. Food and Drug Administration (FDA) seeking approval of SIMPONI ARIA® (golimumab) |
| 2017-10-20 | Janssen Research & Development, LLC | Regulatory Janssen Receives Two U.S. FDA Approvals for Simponi aria® (Golimumab) for the Treatment of Adults with Active Psoriatic Arthritis or Active Ankylosing Spondylitis jnj.com ↗
Janssen Receives Two U.S. FDA Approvals for Simponi aria® (Golimumab) for the Treatment of Adults with Active Psoriatic Arthritis or Active Ankylosing Spondylitis |
| 2016-05-27 | Janssen Research & Development, LLC | Regulatory SIMPONI® RECEIVES CHMP POSITIVE OPINION FOR TREATMENT OF POLYARTICULAR JUVENILE IDIOPATHIC ARTHRITIS jnj.com ↗
SIMPONI® RECEIVES CHMP POSITIVE OPINION FOR TREATMENT OF POLYARTICULAR JUVENILE IDIOPATHIC ARTHRITIS |
| 2015-09-02 | Janssen Research & Development, LLC | Regulatory U.S. FDA Approves Update Of SIMPONI ARIA® (Golimumab For Infusion) Label To Include Improvement In Both Physical and Emotional Measures Of Health When Treating Moderately To Severely Active Rheumatoid Arthritis jnj.com ↗
Janssen Biotech, Inc. announced today the approval of a U.S. Food and Drug Administration (FDA) Supplemental Biologics License Application (sBLA) for SIMPONI ARIA® (golimumab for infusion) for the treatment of moderately to severely active rheumatoid arthritis (RA) to include measures of physical and mental health reported by patients through the Medical Outcomes Study Short Form-36 questionnaire (SF-36). |
| 2015-06-26 | Janssen Research & Development, LLC | Regulatory SIMPONI® Receives European Commission Approval for Treatment of Non-Radiographic Axial Spondyloarthritis jnj.com ↗
The EC approval follows a positive opinion issued by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) in May 2015 recommending the use of SIMPONI for this indication. |
| 2015-05-22 | Janssen Research & Development, LLC | Regulatory SIMPONI® Receives CHMP Positive Opinion for Treatment of Non-Radiographic Axial Spondyloarthritis in Europe jnj.com ↗ |
| 2013-10-28 | Janssen Research & Development, LLC | Results NEW TWO-YEAR RESULTS SHOW SIMPONI® ARIA™ (GOLIMUMAB) FOR INFUSION INHIBITED RADIOGRAPHIC PROGRESSION IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS jnj.com ↗
New two-year results of a Phase 3 study sponsored by Janssen Research & Development, LLC (Janssen) showed that SIMPONI® ARIA™ (golimumab) for infusion in combination with methotrexate inhibited radiographic progression in patients with moderately to severely active rheumatoid arthritis (RA) at week 24, and continued to inhibit radiographic progression through weeks 52 and 100. |
| 2013-09-23 | Janssen Research & Development, LLC | Regulatory SIMPONI® Receives European Commission Approval For Treatment Of Moderately To Severely Active Ulcerative Colitis jnj.com ↗
Janssen Biologics B.V. ("Janssen") announced today that the European Commission has approved SIMPONI® (golimumab) for the treatment of moderately to severely active ulcerative colitis (UC) in adult patients who have had an inadequate response to conventional therapy including corticosteroids and 6 -mercaptopurine (6-MP) or azathioprine (AZA), or who are intolerant to or have medical contraindications for such therapies. |
| 2013-07-26 | Janssen Research & Development, LLC | Regulatory SIMPONI® Receives CHMP Positive Opinion For Treatment Of Ulcerative Colitis jnj.com ↗
Janssen Biologics B.V. ("Janssen") announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending the use of SIMPONI® (golimumab) for the treatment of adult patients with moderately to severely active ulcerative colitis (UC) who have had an inadequate response to conventional therapy or who are intolerant to or have medical contraindications for such therapies. |
| 2013-07-18 | Janssen Research & Development, LLC | Regulatory SIMPONI® ARIA™ (golimumab) For Infusion Receives FDA Approval For Treatment Of Moderately To Severely Active Rheumatoid Arthritis jnj.com ↗
Janssen Biotech, Inc. announced today the U.S. Food and Drug Administration (FDA) approval of SIMPONI® ARIA™ (golimumab) for infusion for the treatment of adults with moderately to severely active rheumatoid arthritis (RA) in combination with methotrexate. |
| 2013-05-15 | Janssen Research & Development, LLC | Regulatory SIMPONI® (Golimumab) Receives FDA Approval For Ulcerative Colitis jnj.com ↗
SIMPONI® (Golimumab) Receives FDA Approval For Ulcerative Colitis |
| 2011-07-01 | Tanabe Pharma Corporation | Regulatory Approval for "SIMPONI® Subcutaneous Injection 50mg Syringe (Generic Name: Golimumab)" for Treatment of Rheumatoid Arthritis tanabe-pharma.com ↗
Approval for "SIMPONI® Subcutaneous Injection 50mg Syringe (Generic Name: Golimumab)" for Treatment of Rheumatoid Arthritis |
All press releases naming this drug 48 releases
Evidence & citations 13 cited values
Every value below carries the sentence it was read from. 113 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Golimumab | “This is a multicenter, prospective study of dose adjustment of golimumab in patients with ulcerative colitis who will initiate golimumab treatment (naïve to anti-TNF) or after...” NCT03669029 ↗102“This study aimed to show equivalent efficacy, pharmacodynamics, pharmacokinetics (PK), safety, and immunogenicity of biosimilar BAT2506 to reference golimumab (Ref-GLM) in...” PMID 42021476 ↗ Apr 2026 “To be given subcutaneously via a prefilled syringe/autoinjector (etanercept, adalimumab, certolizumab pegol, golimumab) or intravenously via infusion (infliximab) at increasing...” NCT05115903 ↗ “TNF-a inhibitors: Etanercept (Enbrel, Benapali), Infliximab (Remicade, Inflectra, Flixabi), Adalimumab (Humira, Imraldi, AMGEVITA), Certolizumabpegol (Cimzia), Golimumab (Simponi)” NCT04378621 ↗ “An approved stable subcutaneous formulation of one of the following TNF inhibitors may include adalimumab, certolizumab, etanercept, or golimumab.” NCT02862574 ↗ “The treatment effect of golimumab, a human monoclonal antibody against tumor necrosis factor (TNF)-alpha, in severe persistent asthma is unknown.” PMID 19136369 ↗ Jan 2009 “golimumab: 50mg every month in subcutaneous injection, in case of overweight (\>100kg) an inadequate response, 100mg every month is allow” NCT03445845 ↗ “Participants were randomised to anakinra or to a TNFi (i.e., adalimumab, certolizumab pegol, etanercept, infliximab, or golimumab)” PMID 31513665 ↗ Sep 2019 “Patients were randomised to golimumab (50 mg SC monthly)+MTX (n=26) (TNFi arm) or matched placebo+MTX (n=25) (MTX arm).” PMID 30808625 ↗ Feb 2019 “Simponi (Golimumab) is a recombinant human IgG1қ mAb developed as a subcutaneous injection” NCT05842213 ↗ “golimumab if initial failure to the receptor fusion protein, etanercept.” NCT03100253 ↗ |
| Known as | CNTO 148 | “An Efficacy and Safety Study of Golimumab (CNTO 148) in Participants With Moderately to Severely Active Ulcerative Colitis” NCT00488631 ↗9“An Efficacy and Safety Study of Golimumab (CNTO 148) in Participants With Moderately to Severely Active Ulcerative Colitis” NCT00487539 ↗ “subcutaneous injections of Golimumab (CNTO 148), 50 or 100 mg, at either 2- or 4- week intervals” NCT00207714 ↗ “Golimumab (CNTO 148); placebo SC injections every 4 wks thru wk 20” NCT00265083 ↗ “golimumab (CNTO 148) in subjects with active rheumatoid arthritis” NCT00299546 ↗ “Biological: CNTO 148 / Golimumab” NCT00675649 ↗ “CNTO 148 (Golimumab)” NCT01230827 ↗ |
| Known as | Drug: Golimumab (Simponi) | “Drug: Golimumab (Simponi)” NCT02456363 ↗ |
| Known as | GLM | “golimumab (GLM) Program of Ulcerative Colitis Utilizing an Investigational Treatment (PURSUIT)-maintenance (-M) and long-term extension (-LTE) studies” PMID 37691729 ↗ Aug 20231“were randomized to either intravenous golimumab (IV GLM) + subcutaneous golimumab (SC GLM) or SC GLM alone.” NCT00975130 ↗ |
| Known as | GOL | “Assess 5-year golimumab (GOL) safety in rheumatoid arthritis (RA), psoriatic arthritis (PsA), and ankylosing spondylitis (AS).” PMID 27803138 ↗ Nov 20165“OBJECTIVE: Evaluate effects of intravenous (IV) golimumab (GOL) on radiographic progression in psoriatic arthritis (PsA).” PMID 30770519 ↗ Feb 2019 “To evaluate the safety and efficacy of intravenous golimumab (GOL) in patients with active ankylosing spondylitis (AS).” PMID 29247154 ↗ Dec 2017 “BACKGROUND: Golimumab (GOL) is registered for moderate to severely active ulcerative colitis (UC).” PMID 29920582 ↗ Jan 2019 “Golimumab （GOL）is a fully-humanized anti-TNF-α monoclonal antibody” NCT04218565 ↗ “Golimumab (GOL) 50mg every 4 weeks” NCT05669833 ↗ |
| Known as | MK-8259 | “This two-part study was to evaluate the effect of golimumab (SCH 900259, MK-8259) in participants with active axial spondyloarthritis (axial SpA).” NCT01453725 ↗ |
| Known as | Ref-GLM | “This study aimed to show equivalent efficacy, pharmacodynamics, pharmacokinetics (PK), safety, and immunogenicity of biosimilar BAT2506 to reference golimumab (Ref-GLM) in...” PMID 42021476 ↗ Apr 2026 |
| Known as | SCH 900259 | “This two-part study was to evaluate the effect of golimumab (SCH 900259, MK-8259) in participants with active axial spondyloarthritis (axial SpA).” NCT01453725 ↗ |
| Known as | Simponi | “This is a randomized (study medication assigned by chance), double-blind (both the physician and subject do not know the assigned study medication) study to assess the safety,...” NCT01258777 ↗11“Personalised Medicine: a Break Through Approach for Early Determination of Anti Tumor Necrosis Factor (TNF) Responders and Non Responders Among Patients With Ulcerative Colitis...” NCT02186886 ↗ “The prefilled syringe with golimumab 50mg (Simponi ®) will be administrated subcutaneously every 4 weeks during a study period of 48 weeks.” NCT01426815 ↗ “assess the safety, tolerability, immune response, pharmacokinetics (what the body does to the drug), of golimumab (Simponi).” NCT01288157 ↗ “Prefilled syringe with golimumab 50mg (Simponi®) administrated subcutaneously, once monthly, for 24 weeks.” NCT02065713 ↗ “The possible TNF inhibitors are: Remicade, Humira, Enbrel, Cimzia, Simponi.” NCT01548768 ↗ “Golimumab (Simponi®)” NCT02779114 ↗ “Golimumab (Simponi)” NCT07149792 ↗ |
| Action | Inhibit | “tumor necrosis factor-alpha blockade” PMID 19136369 ↗ Jan 2009 |
| Modality | Monoclonal antibody | “a human monoclonal antibody” PMID 19136369 ↗ Jan 2009 |
| Route | Subcutaneous | “subcutaneous injections of Golimumab” NCT00207714 ↗ |
| Target | TNF | “against tumor necrosis factor (TNF)-alpha” PMID 19136369 ↗ Jan 2009 |