美国食品和药物管理局批准了两种denosumab生物类似药物作为Prolia和Xgeva的可互换替代品,用于治疗骨质疏松症和与癌症相关的骨问题. The FDA approved two denosumab biosimilars as interchangeable alternatives to Prolia and Xgeva for osteoporosis and cancer-related bone issues.

美国林业发展局批准Biocon Biologics' denosumab生物相似物Bosaya和Aukelso作为Prolia和Xgeva的可互换替代品。 The U.S. FDA has approved Biocon Biologics' denosumab biosimilars, Bosaya and Aukelso, as interchangeable alternatives to Prolia and Xgeva. 两者均被核准用于类似用途,包括治疗高危病人的骨质疏松症和防止癌症病人的骨质并发症。 Both are approved for similar uses, including treating osteoporosis in high-risk patients and preventing bone complications in cancer patients. 它们显示了与参考药物可比的安全性、质量和效力。 They demonstrated comparable safety, quality, and efficacy to the reference drugs. 批准扩大了获得负担得起的生物疗法的机会,两种生物类都获得临时可互换地位。 The approval expands access to affordable biologic therapies, with both biosimilars receiving provisional interchangeability status.