On 18 May 2026, Accord BioPharma announced that the FDA has approved Immgolis™ and Immgolis Intri™ (golimumab) as interchangeable biosimilars to Janssen’s Simponi® and Simponi® Aria, respectively. These are the first golimumab biosimilars to be approved in the US.
The BLA for Bio-Thera/Accord’s golimumab biosimilar was accepted by the FDA for review in July 2025, which followed FDA acceptance of Alvotech/Teva’s BLA for AVT05 (golimumab) in January 2025. However, Alvotech/Teva’s approval was delayed by a Complete Response Letter issued in November 2025, following which Alvotech undertook a “remediation project”. Alvotech plans to resubmit its golimumab BLA to the FDA in Q2/2026.
Immgolis™ and Immgolis Intri™ were developed by Bio-Thera Solutions as BAT2506. In February 2025, Bio-Thera and Intas Pharmaceuticals entered into an exclusive US commercialisation and licence agreement for BAT2506, under which Intas’ subsidiary Accord BioPharma is responsible for commercialising the product in the US, while Bio-Thera retains responsibility for development, manufacturing and supply.
The US launch date for Immgolis™ and Immgolis Intri™ is uncertain given ongoing US litigation relating to BAT2506. In March 2026, Janssen commenced BPCIA patent infringement proceedings against Bio-Thera Solutions/Accord BioPharma alleging infringement of 17 patents. A preliminary injunction application by Janssen is due to be heard in August or the beginning of September 2026.
Bio-Thera received a positive CHMP opinion in December 2025 for BAT2506, which was EU approved in February 2026 under the name Gotenfia®. Gotenfia® is commercialised in the EU and UK by STADA.