On 16 January 2025, Bio-Thera announced that it has signed an exclusive licence and commercialisation agreement with Turkish company, World Medicine, in relation to Bio-Thera’s BAT2206 (ustekinumab), biosimilar to Janssen’s Stelara®.
Under the terms of the agreement, Bio-Thera will manufacture BAT2206 in China and World Medicine will be responsible for regulatory approval, importation and commercialisation of the product in Turkey.
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.
In December 2024, Bio-Thera announced a partnership with Tabuk Pharmaceuticals to commercialise BAT2206 in Saudi Arabia. In October 2024, Bio-Thera and Gedeon Richter announced they had entered into an exclusive commercialisation and licence agreement for BAT2206, under which Richter has exclusive rights to commercialise the product in the European Union, the UK, Switzerland and selected other countries.