Molecule
Golimumab is a tumor necrosis factor blocker indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA), among other approved uses. It is available as injection for subcutaneous and intravenous use. MedsAcross supplies Golimumab for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
From the regulator-approved product information. Each section names its source.
SIMPONI is a tumor necrosis factor (TNF) blocker indicated for the treatment of: adult patients with moderately to severely active rheumatoid arthritis (RA) in combination with methotrexate adult patients with active psoriatic arthritis (PsA) alone, or in combination with methotrexate adult patients with active ankylosing spondylitis (AS) adult and pediatric patients weighing at least 15 kg with moderately to severely active ulcerative colitis (UC)
Source: US FDA prescribing information
Golimumab is a human monoclonal antibody that binds to both the soluble and transmembrane bioactive forms of human TNFα. This interaction prevents the binding of TNFα to its receptors, thereby inhibiting the biological activity of TNFα (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 TNFα 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. TNFα is an important mediator of the articular inflammation that is characteristic of these diseases.
Source: US FDA prescribing information
RA, PsA, and AS: 50 mg administered by subcutaneous injection once a month. UC: The recommended dosage and administration by subcutaneous injection in adults and pediatric patients weighing at least 15 kg is shown in the table. Recommended Dosage Weight for Patients with UC Week 0 Week 2 Week 6 and every 4 weeks thereafter Adults and pediatric patients 40 kg and greater For pediatric patients weighing 15 kg or greater, administer the appropriate dose using the prefilled syringe (50 mg/0.5 mL or 100 mg/mL). 200 mg 100 mg 100 mg Pediatric patients at least 15 kg to less than 40 kg 100 mg 50 mg 50 mg
Source: US FDA prescribing information
None. None
Source: US FDA prescribing information
Boxed warning (serious infections and malignancy warning: serious infections and malignancy): 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. Discontinue SIMPONI if a patient develops a serious infection or sepsis. Serious Infections: Do not start SIMPONI during an active infection. If an infection develops, monitor carefully, and stop SIMPONI if infection becomes serious. Invasive Fungal Infections: For patients who develop a systemic illness on SIMPONI, consider empiric antifungal therapy for those who reside in or travel to regions where mycoses are endemic. Malignancies: Incidence of lymphoma was greater than in the general U.S. population.
Source: US FDA prescribing information
The following clinically significant adverse reactions are described elsewhere in the labeling: Serious Infections Malignancies Congestive Heart Failure Demyelinating Disorders Hepatitis B Reactivation Autoimmunity Hematologic Cytopenias Hypersensitivity Reactions Most common adverse reactions in adults (incidence > 5%) are upper respiratory tract infection, nasopharyngitis, injection site reactions
Source: US FDA prescribing information
Abatacept: Increased risk of serious infection. Anakinra: Increased risk of serious infection. Live vaccines/therapeutic infectious agents: Avoid use with SIMPONI.
Source: US FDA prescribing information
Refrigerate SIMPONI between 36 °F to 46 °F (2 °C to 8 °C) in the original carton to protect from light until the time of use. Do not freeze. If needed, SIMPONI may be stored at room temperature up to 77 °F (25 °C) for a maximum single period of 30 days in the original carton to protect from light. Once a syringe or autoinjector has been stored at room temperature, do not return the product to the refrigerator. If not used within 30 days at room temperature, discard SIMPONI. Do not shake.
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
3 presentations of Golimumab, sorted by availability.
| Medicine | Manufacturer | Register | Availability |
|---|---|---|---|
| Simponi 100 mg/1 mL injectionSubcutaneous Cold chain | Janssen Biotech | US FDA | Available on request |
| Simponi 50 mg/0.5 mL injectionSubcutaneous Cold chain | Janssen Biotech | US FDA | Available on request |
| Simponi Aria 50 mg/4 mL injectionIntravenous Cold chain | Janssen Biotech | US FDA | Available on request |
2 brand names across 1 markets.
United States
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
Conditions linked to Golimumab in public data. This is not a list of approved uses, see the clinical information.
Yes, on request. MedsAcross lists 3 presentations of Golimumab and sources them for licensed hospitals, importers and physicians against valid import documents.
The catalogue lists 2 brand names for Golimumab, including Simponi, Simponi Aria.
Yes. The US FDA first approved Golimumab on 24 April 2009, according to Drugs@FDA.
Yes. Golimumab has a central EU marketing authorisation (status: authorised), according to European Medicines Agency data.
At least one listed presentation of Golimumab must be kept cold, so it is shipped in temperature-controlled packaging. Check the storage line on each presentation.
Golimumab is classified under ATC code L04AB06 (Golimumab).
Tell us the strength, quantity and destination country. Our team replies with availability, lead time and the import documents needed.