Bio-Thera Solutions Inc., a commercial-stage biopharmaceutical company, announced that the European Commission (EC) has approved BAT2206 (ustekinumab), a biosimilar referencing Janssen’s Stelara, following a positive opinion from the EMA’s CHMP on June 19, 2025. The product will be marketed in Europe by Gedeon Richter under the brand name Usymro. This marks Bio-Thera’s third EC-approved product.

Shengfeng Li, CEO of Bio-Thera Solutions, said, “The EC approval of BAT2206 is another significant milestone for us. It reflects our commitment to expanding patient access in Europe through our growing biosimilar pipeline.”

Bio-Thera and Gedeon Richter entered into a licensing and commercialization agreement in October 2024, under which Bio-Thera is responsible for product development and manufacturing, while Gedeon Richter holds exclusive rights to market Usymro in the EU, UK, Switzerland, and select other regions.

Usymro, a biosimilar to Stelara, is a human monoclonal antibody that inhibits IL-12 and IL-23 activity, targeting key pathways involved in chronic inflammation. By blocking these cytokines, the biosimilar helps manage immune disorders such as psoriasis, psoriatic arthritis, and Crohn’s disease.

Headquartered in Guangzhou, China, Bio-Thera focuses on developing both innovative therapeutics and biosimilars to address cancer, autoimmune, cardiovascular, ophthalmic, and other unmet medical needs.