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 FDA | CDER | Small Business and Industry Assistance
INDUSTRY NEWS
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FDA approves first interchangeable biosimilars to Simponi and Simponi Aria (golimumab) to treat rheumatoid arthritis and ulcerative colitis
On May 15, 2026, the Food and Drug Administration FDA approved Immgolis (golimumab-sldi) as an interchangeable biosimilar biological product to Simponi (golimumab) and Immgolis Intri (golimumab-sldi) as an interchangeable biosimilar biological product to Simponi Aria (golimumab) to treat rheumatoid arthritis and ulcerative colitis. Immgolis and Immgolis Intri are the first biosimilars approved for Simponi and Simponi Aria, respectively. Immgolis is administered by subcutaneous injection in a single-dose prefilled syringe and Immgolis Intri is administered as an intravenous infusion prepared from a single dose vial.
A biosimilar product is a biological product that is highly similar to and has no clinically meaningful differences from an FDA-approved reference product. As a biosimilar product, Immgolis and Immgolis Intri can be used in place of Simponi and Simponi Aria. As an interchangeable biosimilar, Simponi and Simponi Aria may be substituted at the pharmacy for the reference product, depending on state laws.
Immgolis and Immgolis Intri is a monoclonal antibody that binds to a protein called tumor necrosis factor alpha (TNFα). By binding TNFα, golimumab products stop it from triggering inflammation which helps improve signs and symptoms of these diseases.
The expected side effects and adverse events for Immgolis and Immgolis Intri are consistent with those observed with Simponi and Simponi Aria. The most common expected side effects of Immgolis/Immgolis Intri, like Simponi/Simponi Aria, are upper respiratory tract infection, nasopharyngitis, and injection site reactions (incidence > 5%). Golimumab products can cause serious side effects including serious infections and malignancy (cancers). Patients treated with golimumab products are at increased risk for developing serious infections that may lead to hospitalization or death.
The approval was based on comparisons across a broad range of structural and functional product quality attributes, including those known to impact safety and efficacy; a human pharmacokinetic similarity study showed comparable exposure and immunogenicity results in subjects treated with Immgolis and subjects treated with Simponi. The totality of these data supported FDA approval of Immgolis as an interchangeable biosimilar to Simponi and Immgolis Intri as an interchangeable biosimilar to Simponi Aria.
Immgolis and Immgolis Intri (golimumab-sldi) is the 86th biosimilar product approved in the U.S for the 21st unique reference product. The availability of biosimilar and interchangeable products can provide more treatment options to patients, potentially lowering treatment costs and enabling greater access for more patients.
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The Small Business and Industry Assistance (SBIA) program in the Center for Drug Evaluation and Research provides guidance, education and updates for regulated industry.
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