Gedeon Richter to Commercialize Bio-Thera's Biosimilar in Europe
Gedeon Richter Plc. and Bio-Thera Solutions have signed an exclusive agreement for the commercialization of BAT2206, a proposed biosimilar to Stelara®, in the EU and UK. Bio-Thera will continue development and manufacturing.
Gedeon Richter Plc. has entered into an exclusive commercialization and license agreement with Bio-Thera Solutions for the product BAT2206, a proposed biosimilar. The agreement grants Richter exclusive rights to commercialize the product in the European Union, the UK, Switzerland, and select other countries.
Under the terms of the agreement, Bio-Thera Solutions will retain responsibility for the development, manufacturing, and supply of BAT2206. The company filed for regulatory approval with the European Medicines Agency (EMA) on July 1, 2024.
Bio-Thera will receive an upfront payment of USD 8.5 million, with potential for additional development and commercial milestones totaling up to USD 101.5 million, subject to certain conditions. BAT2206 is a proposed biosimilar referencing Janssen's Stelara® (ustekinumab), a treatment for inflammatory and autoimmune conditions such as Crohn's disease and plaque psoriasis.
Dr. Shengfeng Li, CEO of Bio-Thera Solutions, stated that Richter is the appropriate partner to bring BAT2206 to patients in the EU and UK. Dr. Erik Bogsch, Head of Richter's Biotechnology Business Unit, noted that this deal reinforces Richter's biosimilar portfolio in Europe, following recent acquisitions and a denosumab filing.