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BAT2206 is Bio-Thera's third EC-approved product.
August 26, 2025
By: Charlie Sternberg
The European Commission (EC) has approved Bio-Thera Solutions Inc.’s BAT2206 (ustekinumab), a biosimilar referencing Stelara, following a positive opinion from the EMA’s CHMP on June 19, 2025. Gedeon Richter has the rights to market BAT2206 in Europe under the brand name USYMRO. BAT2206 is Bio-Thera’s third EC-approved product.
“The EC approval of BAT2206 is another significant accomplishment for Bio-Thera as it marks Bio-Thera’s third EC-approved product,” said Shengfeng Li, CEO at Bio-Thera. “Bio-Thera is committed to expanding access for patients in Europe to important treatments through the continued development of our growing biosimilar pipeline of approved products.”
Bio-Thera and Gedeon Richter entered into a license and commercialization agreement for USYMRO (BAT2206) in October 2024. Under the terms of the agreement, Bio-Thera is responsible for the development and manufacturing of the product, and Gedeon Richter obtained exclusive rights to commercialize the medicine in the EU, the UK and Switzerland, and selected other countries.
Bio-Thera Solutions and STADA Arzneimittel AG, a consumer healthcare medicines company, recently agreed to extend their biosimilars alliance to cover tocilizumab.
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