FDA即将审查诺华制药(NVS.US)旗下山德士的仿制药申请

智通财经2023-02-06

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...

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