Core Viewpoint - The approval of BILDYOS and BILPREVDA by the European Commission marks a significant milestone for the company, enhancing its international market presence and product influence [1][2]. Product Approval - BILDYOS (60 mg/mL) is approved for treating osteoporosis in high-risk postmenopausal women and men, bone loss in prostate cancer patients undergoing hormone ablation, and bone loss related to long-term systemic glucocorticoid treatment in high-risk adult patients [1]. - BILPREVDA (120 mg/1.7 mL) is approved for preventing bone-related events in adults with advanced bone malignancies and treating patients with giant cell tumors of bone that cannot be surgically removed or may lead to severe functional impairment [1]. Regulatory Basis - The approval is based on comprehensive reviews of comparative studies between HLX14 (the biosimilar) and its reference drug Prolia, demonstrating high similarity in quality, safety, and efficacy [2]. - The European Medicines Agency's guidelines allow extrapolation of clinical safety and efficacy data to other approved indications of the reference drug [2]. International Recognition - Following the approval in the United States, the EU approval of BILDYOS and BILPREVDA represents further recognition of the company's products in major international markets, supporting its globalization strategy [2].
复宏汉霖(02696)：欧盟委员会批准 HLX14(地舒单抗)两个产品用于特定人群骨质疏松症治疗等适应症