Simponi
| Monoclonal antibody | |
|---|---|
| Type | Whole antibody |
| Source | Human |
| Target | TNFα |
| Clinical data | |
| Trade names | Simponi |
| AHFS/Drugs.com | Monograph |
| MedlinePlus | a610010 |
| License data | |
| Routes of administration |
Subcutaneous injection |
| ATC code | L04AB06 (WHO) |
| Legal status | |
| Legal status |
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| Identifiers | |
| CAS Number |
476181-74-5 
|
| ChemSpider | none |
| UNII |
91X1KLU43E 
|
| KEGG |
D04358
|
| ChEMBL |
CHEMBL1201833
|
| ECHA InfoCard | 100.226.360 |
| Chemical and physical data | |
| Formula | C6530H10068N1752O2026S44 |
| Molar mass | 147 kg/mol |
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Golimumab (CNTO 148) is a human monoclonal antibody which is used as an immunosuppressive drug and marketed under the brand name Simponi. Golimumab targets tumor necrosis factor alpha (TNF-alpha), a pro-inflammatory molecule and hence is a TNF inhibitor.
Golimumab was developed by Janssen Biotech, Inc. (formerly Biotech, Inc.) which also markets the product in the United States. The Janssen Pharmaceutical Companies market Simponi in Canada, Central and South America, the Middle East, Africa and Asia Pacific. In Europe, Russia and Turkey, Simponi distribution rights are held by Schering-Plough (Ireland) Company, a subsidiary of Merck & Co., Inc. In Japan, Indonesia and Taiwan, distribution rights are held by Mitsubishi Tanabe Pharma Corporation.
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.
European Medicines Agency (EMA) has approved the use of golimumab as a treatment for rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis. 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.
Golimumab is approved in Canada and the United States as a once monthly subcutaneous treatment for adults with moderately to severely active rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis. 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.
Large, double-blind randomized controlled trials in patients with rheumatoid arthritis have shown that golimumab in combination with methotrexate was more effective than methotrexate alone.
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Wikipedia