On 9 October 2024, Bio-Thera Solutions and Gedeon Richter announced that they have entered into an exclusive commercialisation and license agreement for BAT2206, biosimilar to Janssen’s Stelara® (ustekinumab). Pursuant to the agreement, Bio-Thera continues to be responsible for the development, manufacturing, and supply of BAT2206, with Gedeon Richter having exclusive rights to commercialise the product in the European Union, the UK, Switzerland and selected other countries. Bio-Thera is set to receive an upfront payment of US$8.5 million, plus development and commercial milestones of up to US$101.5 million, subject to the fulfillment of certain conditions.
On 24 July 2024, Bio-Thera Solutions announced that the FDA BLA and EMA MAA for its BAT2206 have both been accepted. BAT2206 is the first biosimilar to Janssen’s Stelara® developed by a Chinese company to be submitted to the FDA or EMA for approval.
Bio-Thera’s BLA for BAT2206 is also currently under review by the China National Medicinal Product Administration.