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
Research Report
Golimumab (Simponi®, Simponi Aria®): A Comprehensive Pharmacological and Clinical Review
I. Introduction and Overview
1.1. Executive Summary
Golimumab is a fully human immunoglobulin G1 kappa (IgG1κ) monoclonal antibody that functions as a high-affinity antagonist of tumor necrosis factor-alpha (TNF-α), a pivotal cytokine in the pathophysiology of numerous inflammatory conditions.[1] Developed and marketed by Janssen Biotech, Inc., a subsidiary of Johnson & Johnson, golimumab represents a significant therapeutic advancement in the management of chronic, immune-mediated inflammatory diseases.[3] It is available under two distinct brand names corresponding to its route of administration: Simponi® for subcutaneous (SC) injection and Simponi Aria® for intravenous (IV) infusion.[3] The fundamental therapeutic principle of golimumab is the neutralization of excess TNF-α, which in turn interrupts the downstream inflammatory cascade responsible for tissue damage and clinical symptoms. This mechanism has demonstrated efficacy in reducing disease activity, improving physical function, and, in several key indications, inhibiting the progression of structural joint damage.[5]
1.2. Drug Identification
- [Generic Name:] Golimumab [2]
- [DrugBank ID:] DB06674 [2]
- [CAS Number:] 476181-74-5 [1]
- [Type:] Biotech, Monoclonal Antibody (mAb), Protein-Based Therapy [2]
- [Other Names:] CNTO-148 [3]
- [Chemical Formula & Weight:] The protein has a chemical formula of C6530H10068N1752O2026S44 and an average molecular weight of 146,943.1937 Daltons.[2]
1.3. Place in Therapy
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
---|---|---|---|---|---|
2025/08/24 | Not Applicable | Not yet recruiting | |||
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 |
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 |
---|---|---|---|---|---|
No NMPA approvals found for this drug. |
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 |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
---|---|---|---|---|---|
SIMPONI | 02324776 | Solution - Subcutaneous | 50 MG / 0.5 ML | 6/22/2009 | |
SIMPONI | 02413183 | Solution - Subcutaneous | 100 MG / 1.0 ML | 10/3/2013 | |
SIMPONI | 02324784 | Solution - Subcutaneous | 50 MG / 0.5 ML | 6/22/2009 | |
SIMPONI | 02413175 | Solution - Subcutaneous | 100 MG / 1.0 ML | 10/3/2013 | |
SIMPONI I.V. | 02417472 | Solution - Intravenous | 50 MG / 4.0 ML | 12/12/2013 |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
---|---|---|---|---|---|
SIMPONI 50 MG SOLUCION INYECTABLE EN PLUMA PRECARGADA | 09546001 | SOLUCIÓN INYECTABLE EN PLUMA PRECARGADA | Diagnóstico Hospitalario | Commercialized | |
SIMPONI 50mg SOLUCION INYECTABLE EN PLUMA PRECARGADA | 09546001IP | SOLUCIÓN INYECTABLE EN JERINGA PRECARGADA | Diagnóstico Hospitalario | Not Commercialized | |
SIMPONI 100 MG SOLUCION INYECTABLE EN PLUMA PRECARGADA | 109546005 | SOLUCIÓN INYECTABLE EN PLUMA PRECARGADA | Diagnóstico Hospitalario | Commercialized | |
SIMPONI 50 MG SOLUCION INYECTABLE EN PLUMA PRECARGADA | 09546001IP1 | SOLUCIÓN INYECTABLE EN PLUMA PRECARGADA | Diagnóstico Hospitalario | Not Commercialized |
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No Philippines FDA approvals found for this drug. |
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No Saudi SFDA approvals found for this drug. |
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No Malaysia NPRA approvals found for this drug. |
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
---|---|---|---|---|---|
No UK EMC drug information found for this drug. |
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