 Cartoon representation of the antibody golimumab'svariable fragment. The heavy and light chain fragments are coloured blue and yellow, respectively. From PDB entry5yoy | |
| Monoclonal antibody | |
|---|---|
| Type | Whole antibody |
| Source | Human |
| Target | TNFα |
| Clinical data | |
| Trade names | Simponi, Simponi Aria |
| Other names | CNTO-148[1] |
| AHFS/Drugs.com | Monograph |
| MedlinePlus | a610010 |
| License data | |
| Pregnancy category |
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| Routes of administration | Subcutaneous |
| ATC code | |
| Legal status | |
| Legal status | |
| Identifiers | |
| CAS Number | |
| DrugBank | |
| ChemSpider |
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| UNII | |
| KEGG | |
| ChEMBL | |
| ECHA InfoCard | 100.226.360 |
| Chemical and physical data | |
| Formula | C6530H10068N1752O2026S44 |
| Molar mass | 146945.25 g·mol−1 |
Golimumab, sold under the brand nameSimponi, is ahumanmonoclonal antibody which is used as animmunosuppressive medication.[3][5] Golimumab targetstumor necrosis factor alpha (TNF-alpha), a pro-inflammatory molecule[6] and hence is aTNF inhibitor. Profound reduction inC-reactive protein (CRP) levels, interleukin(IL)-6, intercellular adhesion molecules (ICAM)-1, matrix metalloproteinase(MMP)-3, andvascular endothelial growth factor (VEGF) demonstrates golimumab as an effective modulator of inflammatory markers and bone metabolism.[7] Golimumab is given viasubcutaneous 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 theWorld Health Organization's List of Essential Medicines.[10]
TheEuropean Medicines Agency (EMA) approved the use of golimumab as a treatment forrheumatoid arthritis,psoriatic arthritis andankylosing 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 ofulcerative 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 activerheumatoid arthritis,psoriatic arthritis,juvenile idiopathic arthritis, andankylosing spondylitis.[14]
The most common adverse reactions (incidence >5%) areupper respiratory tract infection,nasopharyngitis, andinjection site reactions.[15]
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]
Golimumab was developed byJanssen Biotech, Inc. (formerlyCentocor 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]
In September 2025, theCommittee for Medicinal Products for Human Use of theEuropean 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]
Large, double-blindrandomized controlled trials in participants withrheumatoid arthritis have shown that golimumab in combination withmethotrexate is more effective than methotrexate alone.[17] TheNational 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]
There is preliminary evidence for golimumab as a treatment option forocular inflammation.[20]
