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Golimumab

Golimumab, sold under the brand name Simponi, is a human monoclonal antibody which is used as an immunosuppressive medication.[2][4] Golimumab targets tumor necrosis factor alpha (TNF-alpha), a pro-inflammatory molecule[2][6] 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) demonstrates golimumab as an effective modulator of inflammatory markers and bone metabolism.[7] Golimumab is given via subcutaneous injection.[2][4][8]

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.

Golimumab is a therapeutic alternative on the World Health Organization's List of Essential Medicines.[9]

Medical uses

The European Medicines Agency (EMA) approved the use of golimumab as a treatment for rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis.[4][10] Golimumab was approved for the treatment by the US Food and Drug Administration (FDA) as well as the European Medicines Agency (EMA) in 2013 for the treatment of ulcerative colitis.[11][12]

Golimumab is approved in Canada[1] and the United States[2] as a once monthly subcutaneous treatment for adults with moderately to severely active rheumatoid arthritis, psoriatic arthritis, juvenile idiopathic arthritis, and ankylosing spondylitis.[13]

Adverse effects

The most common adverse reactions (incidence >5%) are upper respiratory tract infection, nasopharyngitis, and injection site reactions.[14]

Development

Golimumab binds to both soluble and transmembrane forms of TNFα. The antibody was isolated from a hybridoma clone produced by transgenic mice immunized with human TNFα. The golimumab-secreting clone was selected after being assayed for human light and heavy chains and TNFα-binding. The commercial product is produced in a recombinant cell line cultured by continuous perfusion.[5]

Society and culture

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]

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.[16] Gobivaz was authorized for medical use in the European Union in November 2025.[16][17]

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).[18] Gotenfia was authorized for medical use in the European Union in February 2026.[18][19]

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.[20] 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.[21] In 2011, there were no reported cases of drug-induced lupus-like syndrome.[22]

References

  1. Simponi product information Health Canada, 20 September 2013, retrieved 28 September 2025^
  2. Simponi- golimumab injection, solution DailyMed, 30 September 2019, retrieved 11 November 2020^
  3. Simponi Aria- golimumab solution DailyMed, 2 October 2020, retrieved 11 November 2020^
  4. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged. Simponi EPAR European Medicines Agency (EMA), 17 September 2018, retrieved 11 November 2020^
  5. Golimumab mAbs, 2009^
  6. StatPearls [Internet] StatPearls Publishing, 22 June 2024, retrieved 23 December 2025^
  7. 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^
  8. 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^
  9. The selection and use of essential medicines, 2025: WHO Model List of Essential Medicines, 24th list World Health Organization, 2025^
  10. Simponi (golimumab) Receives FDA Approval as First Once-Monthly Anti-TNF for Treatment of Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing Spondylitis www.drugs.com, retrieved 9 May 2016^
  11. Golimumab for the treatment of ulcerative colitis Clinical and Experimental Gastroenterology, 12 March 2014^
  12. Johnson & Johnson Reports 2008 First-Quarter Results retrieved 28 April 2008^
  13. TNF-alpha inhibitors for ankylosing spondylitis The Cochrane Database of Systematic Reviews, April 2015^
  14. {{Drugs.com|pro|simponi}}^
  15. Simponi Receives European Commission Approval For Treatment Of Non-Radiographic Axial Spondyloarthritis Johnson & Johnson, 26 June 2015, retrieved 9 May 2016^
  16. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged. Gobivaz EPAR European Medicines Agency (EMA), 19 September 2025, retrieved 28 September 2025^
  17. Gobivaz PI Union Register of medicinal products, 19 November 2025, retrieved 1 December 2025^
  18. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged. Gotenfia EPAR European Medicines Agency (EMA), 12 December 2025, retrieved 22 December 2025^
  19. Gotenfia Product information Union Register of medicinal products, 10 February 2026, retrieved 16 February 2026^
  20. Golimumab: in the treatment of rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis BioDrugs, 2009^
  21. Golimumab for the treatment of rheumatoid arthritis after the failure of previous disease-modifying antirheumatic drugs: a NICE single technology appraisal PharmacoEconomics, August 2013^
  22. 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^