Overview
Golimumab is a human IgG1қ monoclonal antibody derived from immunizing genetically engineered mice with human TNFα. Golimumab binds and inhibits soluble and transmembrane human TNFα. Increased TNFα is associated with chronic inflammation. Thus golimumab is indicated for use in adults (i) as an adjunct to methotrexate treatment in patients with moderate to severe active rheumatoid arthritis (RA), (ii) alone or as an adjunct to methotrexate treatment in patients with active psoriatic arthritis (PsA), (iii) as a single agent in patients with active ankylosing spondylitis (AS), and (iv) as a single agent in patients with moderate to severe ulcerative colitis (UC) who require chronic steroids or have experienced intolerance or only a partial response to previous medications. In the U.S. and Canada, golimumab is marketed under the brand name Simponi®. The FDA label includes a black box warning of serious infections and malignancy. Additionally in children and adolescents taking golimumab, there have been lymphoma and other malignancies observed.
Indication
Used in adults (i) as an adjunct to methotrexate treatment in patients with moderate to severe active rheumatoid arthritis (RA), (ii) in patients 2 years old and above with active psoriatic arthritis (PsA), (iii) as a single agent in patients with active ankylosing spondylitis (AS) or in combination with methotrexate, and (iv) as a single agent in patients with moderate to severe ulcerative colitis (UC) who require chronic steroids or have experienced intolerance or only a partial response to previous medications. It is also indicated (v) for the treatment of active polyarticular juvenile idiopathic arthritis (pJIA) in patients 2 years of age and older.
Associated Conditions
- Active Polyarticular Juvenile Idiopathic Arthritis (pJIA)
- Severe Ulcerative Colitis
- Active Ankylosing spondylitis
- Active Psoriatic arthritis
- Moderate Ulcerative colitis
- Moderate, active Rheumatoid arthritis
- Severe, active Rheumatoid arthritis
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2023/07/27 | Phase 2 | Recruiting | |||
2023/05/03 | Phase 3 | Completed | |||
2023/01/03 | Phase 3 | Recruiting | |||
2022/11/30 | Phase 1 | Completed | |||
2022/06/06 | N/A | Completed | |||
2022/04/18 | Phase 1 | Completed | Bio-Thera Solutions | ||
2022/02/16 | Phase 2 | Active, not recruiting | |||
2022/02/16 | Phase 2 | Active, not recruiting | |||
2021/10/08 | Phase 2 | Completed | |||
2021/09/16 | Phase 3 | Completed | Bio-Thera Solutions |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Janssen Biotech, Inc. | 57894-350 | INTRAVENOUS | 50 mg in 4 mL | 7/19/2023 | |
| Janssen Biotech, Inc. | 57894-071 | SUBCUTANEOUS | 100 mg in 1 mL | 11/21/2023 | |
| Janssen Biotech, Inc. | 57894-070 | SUBCUTANEOUS | 50 mg in 0.5 mL | 11/21/2023 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 10/1/2009 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| SIMPONI SOLUTION FOR INJECTION IN PRE-FILLED PEN 45MG/0.45ML | SIN16118P | INJECTION, SOLUTION | 45mg/0.45ml | 3/9/2021 | |
| Simponi® Solution for Injection in Pre-filled Syringe 100 mg/1.0 ml | SIN14735P | INJECTION, SOLUTION | 100mg/1.0ml | 2/23/2015 | |
| Simponi Solution for Injection in Pre-filled Syringe 50 mg/0.5 ml | SIN14105P | INJECTION, SOLUTION | 50 mg/0.5ml | 2/15/2012 | |
| Simponi® I.V. Concentrate for Solution for Infusion 12.5mg/1 ml | SIN14734P | INFUSION, SOLUTION CONCENTRATE | 12.5mg/1 ml in 4 ml vial | 2/23/2015 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Golimumab Injection | 国药准字SJ20170050 | 生物制品 | 注射剂 | 10/10/2024 | |
| Golimumab Injection | 国药准字SJ20202003 | 生物制品 | 注射剂 | 10/10/2024 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| SIMPONI PRE-FILLED SYRINGE 100MG/1ML | N/A | N/A | N/A | 1/15/2016 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| SIMPONI golimumab (rmc) 50 mg/4 mL concentrate for solution for infusion vial | 311990 | Medicine | A | 11/20/2019 | |
| SIMPONI SMARTJECT INJECTOR golimumab (rmc) 50 mg solution for injection pre-filled pen | 153181 | Medicine | A | 11/13/2009 | |
| SIMPONI SMARTJECT INJECTOR golimumab (rmc) 100 mg solution for injection pre-filled pen | 208279 | Medicine | A | 4/2/2014 | |
| SIMPONI golimumab (rmc) 50 mg solution for injection pre-filled syringe | 153767 | Medicine | A | 11/13/2009 | |
| SIMPONI golimumab (rmc) 100 mg solution for injection pre-filled syringe | 208278 | Medicine | A | 4/2/2014 |
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