复星医药子公司两个地舒单抗注射液获欧盟注册批准
Bei Jing Shang Bao·2025-09-19 09:07

Core Viewpoint - Fosun Pharma's subsidiary Shanghai Fuhong Hanlin Biotech has received approval from the European Commission for the marketing authorization applications (MAAs) of two biosimilar products, BILDYOS® and BILPREVDA® [1] Group 1 - The approved products are both injections of dezhushe monoclonal antibody, with specifications of 60mg/mL for BILDYOS® and 120mg/1.7mL for BILPREVDA® [1] - The marketing authorization allows for the sale of these products in all EU member states as well as in Iceland, Liechtenstein, and Norway, which are part of the European Economic Area [1]