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Golimumab

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Golimumab
Cartoon representation of the antibody golimumab's variable fragment. The heavy and light chain fragments are coloured blue and yellow, respectively. From PDB entry 5yoy
Monoclonal antibody
TypeWhole antibody
SourceHuman
TargetTNFα
Clinical data
Trade namesSimponi, Simponi Aria
Other namesCNTO-148[1]
AHFS/Drugs.comMonograph
MedlinePlusa610010
License data
Pregnancy
category
  • AU: C
Routes of
administration		Subcutaneous
ATC code
Legal status
Legal status
Identifiers
CAS Number
DrugBank
ChemSpider
  • none
UNII
KEGG
ChEMBL
ECHA InfoCard100.226.360 Edit this at Wikidata
Chemical and physical data
FormulaC6530H10068N1752O2026S44
Molar mass146945.25 g·mol−1

Golimumab, sold under the brand name Simponi, is a human monoclonal antibody which is used as an immunosuppressive medication.[3][5] Golimumab targets tumor necrosis factor alpha (TNF-alpha), a pro-inflammatory molecule[6] and hence is a TNF inhibitor. Profound 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.[3][5][8]

Golimumab is a tumor necrosis factor alpha (TNF-a) inhibitor.[9] 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.[9] By blocking TNF-a, golimumab reduces the inflammation and other symptoms of the diseases it is used for.[9]

Golimumab is a therapeutic alternative on the World Health Organization's List of Essential Medicines.[10]

Medical uses

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The European Medicines Agency (EMA) approved the use of golimumab as a treatment for rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis.[5][11] 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.[12][13]

Golimumab is approved in Canada[2] and the United States[3] as a once monthly subcutaneous treatment for adults with moderately to severely active rheumatoid arthritis, psoriatic arthritis, juvenile idiopathic arthritis, and ankylosing spondylitis.[14]

Adverse effects

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The most common adverse reactions (incidence >5%) are upper respiratory tract infection, nasopharyngitis, and injection site reactions.[15]

Development

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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.[1]

Society and culture

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Availability

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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.[16]

Biosimilars

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In September 2025, the Committee for Medicinal Products for Human Use 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.[9] The applicant for this medicinal product is Advanz Pharma Limited.[9] 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.[9]

Research

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Rheumatoid arthritis

[edit]

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.[17] 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.[18] In 2011, there were no reported cases of drug-induced lupus-like syndrome.[19]

Uveitis

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There is preliminary evidence for golimumab as a treatment option for ocular inflammation.[20]

References

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  1. ^ a b Mazumdar S, Greenwald D (2009). "Golimumab". mAbs. 1 (5): 422–31. doi:10.4161/mabs.1.5.9286. PMC 2759491. PMID 20065639.
  2. ^ a b "Simponi product information". Health Canada. 20 September 2013. Retrieved 28 September 2025.
  3. ^ a b c d "Simponi- golimumab injection, solution". DailyMed. 30 September 2019. Retrieved 11 November 2020.
  4. ^ "Simponi Aria- golimumab solution". DailyMed. 2 October 2020. Retrieved 11 November 2020.
  5. ^ a b c d "Simponi EPAR". European Medicines Agency (EMA). 17 September 2018. Retrieved 11 November 2020. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  6. ^ Statement On A Nonproprietary Name Adopted By The USAN Council – Golimumab Archived 20 February 2012 at the Wayback Machine, American Medical Association.
  7. ^ Smolen JS, Landewé R, Breedveld FC, Buch M, Burmester G, Dougados M, et al. (March 2014). "EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs: 2013 update". Annals of the Rheumatic Diseases. 73 (3): 492–509. doi:10.1136/annrheumdis-2013-204573. PMC 4079096. PMID 24161836.
  8. ^ Smolen JS, Landewé R, Breedveld FC, Buch M, Burmester G, Dougados M, et al. (March 2014). "EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs: 2013 update". Annals of the Rheumatic Diseases. 73 (3): 492–509. doi:10.1136/annrheumdis-2013-204573. PMC 4079096. PMID 24161836.
  9. ^ a b c d e f "Gobivaz EPAR". European Medicines Agency (EMA). 19 September 2025. Retrieved 28 September 2025. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  10. ^ World Health Organization (2025). The selection and use of essential medicines, 2025: WHO Model List of Essential Medicines, 24th list. Geneva: World Health Organization. hdl:10665/382243.
  11. ^ "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.
  12. ^ Löwenberg M, de Boer NK, Hoentjen F (12 March 2014). "Golimumab for the treatment of ulcerative colitis". Clinical and Experimental Gastroenterology. 7: 53–9. doi:10.2147/CEG.S48741. PMC 3958527. PMID 24648749.
  13. ^ "Johnson & Johnson Reports 2008 First-Quarter Results". Archived from the original on 7 October 2008. Retrieved 28 April 2008.
  14. ^ Maxwell LJ, Zochling J, Boonen A, Singh JA, Veras MM, Tanjong Ghogomu E, et al. (April 2015). "TNF-alpha inhibitors for ankylosing spondylitis". The Cochrane Database of Systematic Reviews. 2015 (4) CD005468. doi:10.1002/14651858.CD005468.pub2. PMC 11200207. PMID 25887212.
  15. ^ FDA Professional Drug Information
  16. ^ "Simponi Receives European Commission Approval For Treatment Of Non-Radiographic Axial Spondyloarthritis". Johnson & Johnson (Press release). 26 June 2015. Archived from the original on 19 May 2016. Retrieved 9 May 2016.
  17. ^ Oldfield V, Plosker GL (2009). "Golimumab: in the treatment of rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis". BioDrugs. 23 (2): 125–35. doi:10.2165/00063030-200923020-00005. PMID 19489653. S2CID 195685167.
  18. ^ Tosh J, Archer R, Davis S, Stevenson M, Stevens JW (August 2013). "Golimumab for the treatment of rheumatoid arthritis after the failure of previous disease-modifying antirheumatic drugs: a NICE single technology appraisal". PharmacoEconomics. 31 (8): 653–61. doi:10.1007/s40273-013-0052-7. PMID 23576019. S2CID 23085023.
  19. ^ Williams VL, Cohen PR (May 2011). "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. 50 (5): 619–25. doi:10.1111/j.1365-4632.2011.04871.x. PMID 21506984. S2CID 21538173.
  20. ^ Rifkin LM, Birnbaum AD, Goldstein DA (August 2013). "TNF inhibition for ophthalmic indications: current status and outlook". BioDrugs. 27 (4): 347–57. doi:10.1007/s40259-013-0022-9. PMID 23568177. S2CID 391892.
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