On 23 March 2026, Bio-Thera Solutions announced that it has entered an exclusive agreement with Intas Pharmaceuticals for the Indian commercialisation of BAT2506 (golimumab), biosimilar to J&J’s Simponi®. According to Bio-Thera, this represents its first biosimilar partnership for supply in India.
The agreement expands upon the companies’ existing exclusive partnerships for the commercialisation and licence of BAT2506 in the US (February 2025) and Canada (October 2025). Bio-Thera has entered commercialisation agreements for BAT2506 in other regions, including SteinCares for Latin America (March 2024), STADA for Europe, the UK and selected other countries (May 2024) and Dr Reddy’s for South East Asia (March 2025).
Bio-Thera’s BLA for BAT2506 was accepted for review by the FDA in July 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.
There is ongoing US litigation relating to Bio-Thera’s biosimilar golimumab. On 3 March 2026, Janssen filed proceedings against Bio-Thera Solutions/Accord BioPharma in the US District Court for the District of Delaware, alleging infringement of 17 patents related to Bio-Thera’s biosimilar golimumab.