Last reviewed 2026-04-20 · How we verify

Simponi (GOLIMUMAB)

Simponi works by binding to tumor necrosis factor, preventing it from interacting with its receptors and thereby reducing inflammation.

Simponi (Golimumab) is a tumor necrosis factor blocker, a type of biologic medication. It was originally developed by Centocor Ortho Biotech Inc and is used to treat various inflammatory conditions, including rheumatoid arthritis, ankylosing spondylitis, and psoriasis. Simponi works by targeting and blocking tumor necrosis factor, a protein that promotes inflammation. It is a small molecule medication and was FDA approved in 2009. Simponi is still patented and has a commercial status of branded medication.

At a glance

Mechanism of action

Golimumab is human monoclonal antibody that binds to both the soluble and transmembrane bioactive forms of human TNF. This interaction prevents the binding of TNF to its receptors, thereby inhibiting the biological activity of TNF (a cytokine protein). There was no evidence of the golimumab antibody binding to other TNF superfamily ligands; in particular, the golimumab antibody did not bind or neutralize human lymphotoxin. Golimumab did not lyse human monocytes expressing transmembrane TNF in the presence of complement or effector cells.Elevated TNF levels in the blood, synovium, and joints have been implicated in the pathophysiology of several chronic inflammatory diseases such as rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis. TNF is an important mediator of the articular inflammation that is characteristic of these diseases. The exact mechanism by which golimumab treats ulcerative colitis is unknown. Golimumab modulated the in vitro bi

Approved indications

• Ankylosing spondylitis
• Juvenile idiopathic arthritis
• Nonradiographic axial spondyloarthritis
• Polyarticular juvenile idiopathic arthritis
• Psoriasis with arthropathy
• Rheumatoid arthritis
• Ulcerative colitis

Boxed warnings

• WARNING: SERIOUS INFECTIONS and MALIGNANCY WARNING: SERIOUS INFECTIONS and MALIGNANCY See full prescribing information for complete boxed warning. Serious infections leading to hospitalization or death including tuberculosis (TB), bacterial sepsis, invasive fungal (such as histoplasmosis), and other opportunistic infections have occurred in patients receiving SIMPONI ARIA ( 5.1 ). Discontinue SIMPONI ARIA if a patient develops a serious infection or sepsis ( 5.1 ). Perform test for latent TB; if positive, start treatment for TB prior to starting SIMPONI ARIA ( 5.1 ). Monitor all patients for active TB during treatment, even if initial latent TB test is negative ( 5.1 ). Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers, of which SIMPONI ARIA is a member ( 5.2 ). SERIOUS INFECTIONS Patients treated with SIMPONI ARIA are at increased risk for developing serious infections that may lead to hospitalization or death [see Warnings and Precautions (5.1) ] . Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids. Discontinue SIMPONI ARIA if a patient develops a serious infection. Reported infections with TNF blockers, of which SIMPONI ARIA is a member, include: Active tuberculosis, including reactivation of latent tuberculosis. Patients with tuberculosis have frequently presented with disseminated or extrapulmonary disease. Test patients for latent tuberculosis before SIMPONI ARIA use and during therapy. Initiate treatment for latent tuberculosis prior to SIMPONI ARIA use. Invasive fungal infections including histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis, blastomycosis and pneumocystosis. Patients with histoplasmosis or other invasive fungal infections may present with disseminated, rather than localized, disease. Antigen and antibody testing for histoplasmosis may be negative in some patients with active infection. Consider empiric antifungal therapy in patients at risk for invasive fungal infections who develop severe systemic illness. Bacterial, viral, and other infections due to opportunistic pathogens, including Legionella and Listeria. Consider the risks and benefits of treatment with SIMPONI ARIA prior to initiating therapy in patients with chronic or recurrent infection. Monitor patients closely for the development of signs and symptoms of infection during and after treatment with SIMPONI ARIA, including the possible development of tuberculosis in patients who tested negative for latent tuberculosis infection prior to initiating therapy [see Warnings and Precautions (5.1) ] . MALIGNANCY Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF-blockers, of which SIMPONI ARIA is a member [see Warnings and Precautions (5.2) ] .

Common side effects

• Infections
• Upper respiratory tract infection
• Nasopharyngitis
• Injection site reactions
• Sepsis
• Alanine aminotransferase increased
• Aspartate aminotransferase increased
• Tuberculosis
• Anemia
• Liver enzyme elevations
• ALT elevations
• Anti-dsDNA antibodies

Key clinical trials

• Efficacy of Different Biological Treatments in Patients With Inflammatory Bowel Disease After One Year of Treatment in Upper Egypt
• A Study of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Ulcerative Colitis (PHASE2)
• A Study to Assess the Efficacy and Safety of Golimumab in Pediatric Participants With Moderately to Severely Active Ulcerative Colitis (PHASE3)
• A Study of Guselkumab and Golimumab Combination Therapy in Participants With Active Psoriatic Arthritis (PHASE2)
• An Observational Prospective Long-term Exposure Registry of Adult Patients With Moderate-to-Severe Ulcerative Colitis
• Golimumab and Apalutamide for the Treatment of Castration-Resistant Prostate Cancer, TRAMP Study (PHASE2)
• Describing Treatment Patterns and Creating an Updated Treatment Flow in an Ulcerative Colitis Population
• Stand UP to Rheumatoid Arthritis (SUPRA) (NA)

Primary sources

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Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

• Simponi CI brief — competitive landscape report
• Simponi updates RSS · CI watch RSS
• Centocor Ortho Biotech Inc portfolio CI