Bio-Thera Solutions and Accord Biopharma received an FDA approval on May 15, 2026 for the biosimilar forms of Simponi and Simponi Aria. Dubbed Immgolis and Immgolis Intri, this first-in-class golimumab biosimilar should be available before the end of 2026. Â
On May 15, the FDA approved the first golimumab biosimilars, Immgolis and Immgolis Intri (golimumab-sldi) for the reference products Simponi and Simponi Aria, respectively. Commercialized in the US by Accord Biopharma, Immgolis was developed and manufactured by Bio-Thera Solutions. Immgolis is administered by subcutaneous injection in a single-dose prefilled syringe; Immgolis Intri is administered as an intravenous infusion prepared from a single dose vial.
Immgolis is approved for the treatment of severely active rheumatoid arthritis (RA), in combination with methotrexate, and for the treatment of moderately to severely active ulcerative colitis. The Immgolis Intri formulation is approved only for adults with moderately to severely active RA in combination with methotrexate. This does not represent the full set of indications of the reference product, as Simponi is also indicated for the treatment of active psoriatic arthritis alone, or in combination with methotrexate and active ankylosing spondylitis.
“As the first golimumab biosimilars approved in the US, Immgolis and Immgolis Intri represent a meaningful new option for people in the US who are living with the chronic, debilitating autoimmune conditions associated with moderately to severely active rheumatoid arthritis or ulcerative colitis and need more affordable medication,” stated Chrys Kokino, President of Accord North America, in the company’s press release. He added, “This approval answers a clear demand in the US market and helps advance our ambitious goal to bring 20 biosimilars to market by the year 2030.” Launch is expected by Accord BioPharma in the fourth quarter of 2026.
The outlook for biosimilar competition in this category is somewhat limited, in that there has been only one other publicly disclosed golimumab biosimilar. That product, AVT05, is produced by Alvotech and will be commercialized by Teva postapproval. Its initial 351(k) application was accepted by the FDA in January 2025, but the drug makers were issued a complete response letter for manufacturing issues in November 2025.
Golimumab is a TNF inhibitor, and Immgolis will compete against not only the other biosimilar TNF competitors (e.g., adalimumab and infliximab) and their low net prices, but with the approved interleukin biosimilars (e.g., ustekinumab) as well for the same autoimmune indications.
This article was written by our Director of Content, Stanton Mehr. Stan has been writing commentary and reporting news about the biosimilar industry since the submission of the first biosimilar 351(k) application to the FDA 13 years ago. Since that time, BR&R has been tracking the US biosimilar marketplace, with the industry’s original, comprehensive and updated database of biosimilar filings with the FDA.
