On 26 March 2025, Bio-Thera Solutions and Dr Reddy’s announced that they have entered exclusive commercialisation and licence agreements for BAT2206 and BAT2506, biosimilars to J&J/Janssen’s Stelara® (ustekinumab) and Simponi® (golimumab), respectively.
Under the agreement, Bio-Thera will be responsible for developing, manufacturing and supplying BAT2206 and BAT2506 and Dr Reddy’s will commercialise the products in certain Southeast Asian countries, including Cambodia, Indonesia, Malaysia, Philippines, Thailand and Vietnam. Dr Reddy’s will also receive the exclusive commercial rights to BAT2206 in Colombia. The SE Asia deal follows agreements that Bio-Thera entered with Intas/Accord in February 2025 and STADA in May 2024 for the commercialisation of golimumab (BAT2506) in the US and Europe, respectively.
In October 2024, Bio-Thera and Gedeon Richter entered into an exclusive commercialisation and licence agreement for BAT2206 (ustekinumab), under which Richter has exclusive rights to commercialise the product in the European Union, the UK, Switzerland and selected other countries. Bio-Thera’s MAA for BAT2206 (ustekinumab) was accepted by the EMA, and its BLA was accepted by the FDA, in July 2024. A marketing authorisation application is also currently under review by China’s National Medicinal Product Administration.