智通财经APP获悉，瑞士医药巨头诺华制药(NVS.US)旗下子公司山德士(Sandoz)宣布，FDA已接受其拟推出的生物仿制药地诺单抗(denosumab)生物制剂许可证的申请(BLA)，接下来将进行审查。BLA包括分析和临床数据包，以及包括来自I/III期ROSALIA研究的相关数据。
山德士公司总裁兼北美地区负责人Keren Haruvi表示:“denosumab除了是治疗骨癌的重要药物外，在治疗骨质疏松症和潜在预防骨质疏松症相关骨折方面也有着至关重要的作用，许多50岁以上的女性都有患上骨质疏松症的风险。”
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