Golimumab
Overview
Golimumab, sold under the brand name Simponi, is a human monoclonal antibody which is used as an immunosuppressive medication. Golimumab targets tumor necrosis factor alpha (TNF-alpha), a pro-inflammatory molecule and hence is a TNF inhibitor. Reduction in C-reactive protein (CRP) levels, interleukin (IL)-6, intercellular adhesion molecules (ICAM)-1, matrix metalloproteinase (MMP)-3, and vascular endothelial growth factor (VEGF) levels demonstrates golimumab as an effective modulator of inflammatory markers and bone metabolism. Golimumab is given via subcutaneous injection.[1–4] WP
Golimumab is a tumor necrosis factor alpha (TNF-a) inhibitor. Golimumab is a human monoclonal antibody that forms high affinity, stable complexes with both the soluble and transmembrane bioactive forms of human TNF-a, which prevents the binding of TNF-a to its receptors. By blocking TNF-a, golimumab reduces the inflammation and other symptoms of the diseases it is used for.[5] WP
Golimumab is a therapeutic alternative on the World Health Organization's List of Essential Medicines.[6] WP
Uses, dosage and effects
Medical uses
In the European Union, golimumab is indicated for the treatment of ankylosing spondylitis, non-radiographic axial spondyloarthritis, polyarticular juvenile idiopathic arthritis, psoriatic arthritis, rheumatoid arthritis, and ulcerative colitis.[5] WP
In the United States, golimumab is indicated for the treatment of rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, and ulcerative colitis.[1]
Golimumab is approved in Canada for the treatment of adults with moderately to severely active rheumatoid arthritis, psoriatic arthritis, juvenile idiopathic arthritis, and ankylosing spondylitis.[10]
Risks and side effects
Adverse effects
The most common adverse reactions (incidence >5%) are upper respiratory tract infection, nasopharyngitis, and injection site reactions.[1] WP
Research
Rheumatoid arthritis
Large, double-blind randomized controlled trials in participants with rheumatoid arthritis have shown that golimumab in combination with methotrexate is more effective than methotrexate alone. The National Institute for Health and Care Excellence (NICE) stated that treatment with golimumab is recommended for people with rheumatoid arthritis who have failed prior TNFi treatment. In 2011, there were no reported cases of drug-induced lupus-like syndrome.[12]
Legal status
Availability
Golimumab was developed by Janssen Biotech, Inc. (formerly Centocor Biotech, Inc.) which also markets the product in the United States. Janssen markets golimumab in Canada, Central and South America, the Middle East, Africa and Asia Pacific. In the European Union, Russia, and Turkey, golimumab distribution rights are held by MSD (Ireland), a subsidiary of Merck & Co., Inc. In Japan, Indonesia, and Taiwan, distribution rights are held by Mitsubishi Tanabe Pharma Corporation.[15] WP
Biosimilars
In September 2025, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Gobivaz, intended for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, axial spondyloarthritis, and ulcerative colitis. The applicant for this medicinal product is Advanz Pharma Limited. Gobivaz is a biosimilar medicinal product that is highly similar to the reference product Simponi (golimumab), which was authorized in the European Union in October 2009. Gobivaz was authorized for medical use in the European Union in November 2025.[5]
In December 2025, the CHMP adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Gotenfia, intended for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, axial spondyloarthritis, and ulcerative colitis. The applicant for this medicinal product is STADA Arzneimittel AG. Gotenfia is a biosimilar medicinal product that is highly similar to the reference product Simponi (golimumab). Gotenfia was authorized for medical use in the European Union in February 2026.[5]
Chemistry
Harm reduction information
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Sources
- Journal / agency Simponi- golimumab injection, solution. 30 September 2019
- Journal / agency Simponi EPAR. 17 September 2018
- Journal / agency Padda IS, Bhatt R, Parmar M. StatPearls [Internet]. 22 June 2024. PMID 35015417
- Journal / agency Smolen JS, Landewé R, Breedveld FC, Buch M, Burmester G, Dougados M, Emery P, Gaujoux-Viala C, Gossec L, Nam J, Ramiro S, Winthrop K, de Wit M, Aletaha D, Betteridge N, Bijlsma JW, Boers M, Buttgereit F, Combe B, Cutolo M, Damjanov N, Hazes JM, Kouloumas M, Kvien TK, Mariette X, Pavelka K, van Riel PL, Rubbert-Roth A, Scholte-Voshaar M, Scott DL, Sokka-Isler T, Wong JB, van der Heijde D. EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs: 2013 update. Annals of the Rheumatic Diseases. March 2014. doi:10.1136/annrheumdis-2013-204573 · PMID 24161836 · PMC4079096
- Journal / agency Gobivaz EPAR. 19 September 2025
- Other The selection and use of essential medicines, 2025: WHO Model List of Essential Medicines, 24th list. 2025
- Journal / agency Simponi Aria- golimumab solution. 2 October 2020
- Journal / agency Löwenberg M, de Boer NK, Hoentjen F. Golimumab for the treatment of ulcerative colitis. Clinical and Experimental Gastroenterology. 12 March 2014. doi:10.2147/CEG.S48741 · PMID 24648749 · PMC3958527
- Other Johnson & Johnson Reports 2008 First-Quarter Results
- Other Simponi product information. 20 September 2013
- Journal / agency Maxwell LJ, Zochling J, Boonen A, Singh JA, Veras MM, Tanjong Ghogomu E, Benkhalti Jandu M, Tugwell P, Wells GA. TNF-alpha inhibitors for ankylosing spondylitis. The Cochrane Database of Systematic Reviews. April 2015. doi:10.1002/14651858.CD005468.pub2 · PMID 25887212 · PMC11200207
- Journal / agency Oldfield V, Plosker GL. Golimumab: in the treatment of rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis. BioDrugs. 2009. doi:10.2165/00063030-200923020-00005 · PMID 19489653
- Journal / agency Tosh J, Archer R, Davis S, Stevenson M, Stevens JW. Golimumab for the treatment of rheumatoid arthritis after the failure of previous disease-modifying antirheumatic drugs: a NICE single technology appraisal. PharmacoEconomics. August 2013. doi:10.1007/s40273-013-0052-7 · PMID 23576019
- Journal / agency Williams VL, Cohen PR. TNF alpha antagonist-induced lupus-like syndrome: report and review of the literature with implications for treatment with alternative TNF alpha antagonists. International Journal of Dermatology. May 2011. doi:10.1111/j.1365-4632.2011.04871.x · PMID 21506984
- Other Simponi Receives European Commission Approval For Treatment Of Non-Radiographic Axial Spondyloarthritis. 26 June 2015
- Other Gobivaz PI. 19 November 2025
- Other Gotenfia Product information. 10 February 2026
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