MedPath

Golimumab

Generic Name
Golimumab
Brand Names
Simponi
Drug Type
Biotech
CAS Number
476181-74-5
Unique Ingredient Identifier
91X1KLU43E

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

Published: Jul 25, 2025

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 C6530​H10068​N1752​O2026​S44​ and an average molecular weight of 146,943.1937 Daltons.[2]

1.3. Place in Therapy

Continue reading the full research report

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

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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