On 16 July 2025, Bio-Thera Solutions announced that the FDA has accepted for review its Biological Licence Application (BLA) for BAT2506, biosimilar to J&J’s Simponi® (golimumab). BAT2506 is being developed and manufactured by Bio-Thera and will be commercialised in the US by Intas Pharmaceuticals’ subsidiary, Accord Biopharma, under a February 2025 agreement.
The BAT2506 BLA is the second BLA for a golimumab biosimilar to be accepted by the FDA, following acceptance of Alvotech/Teva’s BLA for AVT05 in January 2025, approval of which is expected in Q4 2025.
Accord’s BLA for BAT2506 requests approval for all currently approved indications of Simponi®, including the following treatments for adults: moderately to severely active rheumatoid arthritis (RA) (with methotrexate), active psoriatic arthritis (alone or with methotrexate), active ankylosing spondylitis and moderately to severely active ulcerative colitis.
Bio-Thera has entered commercialisation agreements for BAT2506 in jurisdictions outside the US, including with SteinCares for Latin America (March 2024), STADA in Europe, the UK and selected other countries (May 2024), and Dr Reddy’s for South East Asia (March 2025).
In February 2025, Bio-Thera/STADA’s European marketing authorisation application (MAA) for BAT2506 was accepted by the European Medicines Agency (EMA). In November 2024, Alvotech/Advanz Pharma’s European marketing authorisation application for AVT05 was the first golimumab biosimilar MAA to be accepted anywhere in the world.