FDA Approves First Interchangeable Biosimilars To Simponi And Simponi Aria; Janssen Seeks A Preliminary Injunction To Block Their Launch

On May 15, 2026, the U.S. Food and Drug Administration (“FDA”) approved Accord BioPharma’s IMMGOLIS™ (golimumab-sldi) as an interchangeable biosimilar to Janssen’s SIMPONI® (golimumab), and IMMGOLIS INTRI™ (golimumab-sldi) as an interchangeable biosimilar to SIMPONI ARIA® (golimumab). IMMGOLIS and IMMGOLIS INTRI are the first biosimilars approved for SIMPONI and SIMPONI ARIA.

IMMGOLIS and IMMGOLIS INTRI are both approved for adult patients with moderately to severely active rheumatoid arthritis (“RA”) in combination with methotrexate; IMMGOLIS is also approved for adult patients with moderately to severely active ulcerative colitis (“UC”). IMMGOLIS is administered by subcutaneous injection in a single-dose prefilled syringe, while IMMGOLIS INTRI is administered as an intravenous infusion prepared from a single-dose vial.

The FDA notes that its approval was based on a comprehensive review of scientific evidence demonstrating that IMMGOLIS and IMMGOLIS INTRI are highly similar to SIMPONI and SIMPONI ARIA and that there are no clinically meaningful differences between each biosimilar and its reference product.

The products were developed by Bio-Thera Solutions, which will maintain responsibility for manufacturing and product supply, and will be commercialized in the United States exclusively by Accord BioPharma. Accord BioPharma also stated that it plans to make the products available to patients and providers in the fourth quarter of 2026.

Janssen’s BPCIA litigation against Accord BioPharma and Bio-Thera regarding their golimumab biosimilar products is pending in the U.S. District Court for the District of Delaware. The case was filed on March 3, 2026. On May 6, 2026, Janssen filed a motion for a preliminary injunction. Accord Biopharma and Bio-Thera’s responsive brief is due on June 8, 2026.

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