On 3 March 2026, Janssen Biotech Inc and Janssen Sciences Ireland UC filed proceedings against Bio-Thera Solutions and Accord BioPharma in the US District Court for the District of Delaware, alleging infringement of 17 patents related to golimumab. The Court has granted Janssen’s motion to file the complaint under seal and requires a redacted version to be filed by 11 March 2026. Summons were issued to Accord BioPharma on 4 March 2026, with an answer to the Court due on 25 March 2026.
On 16 July 2025, Bio-Thera announced that the FDA had accepted its BLA for Gotenfiar®(BAT2506), biosimilar to Janssen’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.
Bio-Thera has entered into the following commercialisation agreements for BAT2506, 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) and in December 2025, it received a positive CHMP opinion.