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Bio-Thera’s Biosimilar Referencing Stelara Approved in the EU

BAT2206 is Bio-Thera's third EC-approved product.

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By: Charlie Sternberg

Associate Editor

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...

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