地舒单抗注射液(BILDYOS®

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复星医药(600196.SH):两个地舒单抗注射液产品获欧盟注册批准
智通财经网· 2025-09-19 08:32
Core Viewpoint - Fosun Pharma's subsidiary, Shanghai Fuhong Hanlin Biotechnology Co., Ltd., 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, BILDYOS® (60 mg/mL) and BILPREVDA® (120 mg/1.7 mL), are biosimilars of denosumab, intended for the treatment of osteoporosis in postmenopausal women at high risk of fractures [1] - The marketing authorization allows for the sale of these products in all EU member states as well as in Iceland, Liechtenstein, and Norway [1] - HLX14, the project code for these biosimilars, is developed independently by the group [1]