Accord Healthcare receives positive CHMP opinion for IMULDOSA®, ustekinumab biosimilar to Stelara®
Oct 19, 2024
Ahmedabad (Gujarat) [India], October 19: Accord Healthcare Limited (Accord) announces that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion, recommending marketing authorisation for Imuldosa® (development code: DMB-3115), a biosimilar of Stelara® (ustekinumab), marketed by Janssen Biotech Inc., a subsidiary of Johnson & Johnson. In July 2021, Dong-A ST and Meiji Seika Pharma entered into an exclusive global license agreement with Intas Pharmaceuticals, granting them worldwide commercialization rights for DMB-3115, excluding Korea, Japan, and certain Asian countries. Intas Pharmaceuticals plans to commercialize DMB-3115 through its global subsidiaries, Accord BioPharma in the US and Accord Healthcare in the EU, UK, and Canada.
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