Commercial-stage biopharmaceutical company Bio-Thera Solutions Inc (SH:688177) announced on Tuesday that the European Commission has approved BAT2206 (ustekinumab), a biosimilar referencing Janssen's Stelara.
This follows a positive opinion from the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) on 19 June 2025.
BAT2206 is Bio-Thera's third product approved by the European Commission.
Bio-Thera and Gedeon Richter entered into a licence and commercialisation agreement for BAT2206 in October 2024. Bio-Thera is responsible for development and manufacturing of the product, and Gedeon Richter obtained exclusive rights to commercialise the medicine in the European Union, the UK, Switzerland and selected other countries.
Gedeon Richter has rights to market BAT2206 in Europe under the brand name USYMRO.
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