On 9 October 2025, Bio-Thera Solutions announced that it has entered an exclusive commercialisation and licence agreement for Canada with Intas Pharmaceuticals in relation to BAT2506, biosimilar to J&J’s Simponi® (golimumab).
This expands the existing partnership between the companies in relation to commercialisation of BAT2506 in the US, under a February 2025 agreement. Under that agreement, Intas’ subsidiary, Accord BioPharma, is responsible for commercialising BAT2506 in the US, while Bio-Thera retains responsibility for development, manufacturing and supply. Bio-Thera receives an upfront payment of US$21 million and further development and commercial milestone payments of up to US$143.5 million. The financial arrangements in relation to the Canadian expansion of the partnership have not been published.
Bio-Thera’s BLA for BAT2506 was accepted for review by the FDA in July 2025. In February 2025, the MAA for BAT2506 was accepted for review in Europe, where the biosimilar is being commercialised by STADA under a May 2024 agreement with Bio-Thera. Bio-Thera has also entered into commercialisation agreements for BAT2506 with SteinCares for Latin America (March 2024) and Dr Reddy’s for South East Asia (March 2025).