On 24 December 2024, Bio-Thera Solutions announced that it has entered an exclusive licensing agreement with Tabuk Pharmaceutical Manufacturing Company in relation to the commercialisation of BAT2206 (ustekinumab), biosimilar to J&J/Janssen’s Stelara®.
Bio-Thera’s FDA BLA and EMA MAAA for BAT2206 were accepted in July 2024. A BLA for BAT2206 is also currently under review by China’s National Medicinal Product Administration.
In October 2024, Bio-Thera and Gedeon Richter entered into an exclusive commercialisation and licence agreement for BAT2206, pursuant to which Richter has exclusive rights to commercialise the product in the European Union, the UK, Switzerland and selected other countries.