On 7 February 2025, Bio-Thera announced that the European Medicines Agency (EMA) has accepted its marketing authorisation application (MAA) for BAT2506, biosimilar to J&J’s Simponi® (golimumab).
BAT2506 is being developed and manufactured by Bio-Thera and will be commercialised by STADA in Europe, the UK, Switzerland and certain other countries under a May 2024 exclusive commercialisation agreement.
In November 2024, Alvotech/Advanz Pharma’s European MAA for AVT05 was the first golimumab biosimilar MAA to be filed and accepted anywhere in the world.