Novartis' Sandoz Unit Says US FDA Accepted Biologics License Application for Osteoporosis Biosimilar Treatment
Novartis' Sandoz Unit Says US FDA Accepted Biologics License Application for Osteoporosis Biosimilar Treatment诺华的Sandoz部门表示，美国食品药品管理局接受了骨质疏松症生物仿制药治疗的生物制剂许可申请
07:07 AM EST, 02/06/2023 (MT Newswires) -- Novartis' (NVS) Sandoz unit said Monday the US Food and Drug Administration has accepted its biologics license application for proposed biosimilar denosumab for the potential treatment of various bone conditions.
The application covers all indications for the reference medicines Prolia and Xgeva, including osteoporosis in postmenopausal women and giant cell tumor of the bone.
The submission is supported by analytical and clinical data showing that biosimilar denosumab matches the reference medicine in terms of efficacy and safety, among other parameters.
Novartis shares were off fractionally in recent Monday premarket activity.
Price: 85.7, Change: -0.15, Percent Change: -0.17
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