EMA accepts Sandozs marketing authorization applications for proposed biosimilar denosumab
Sandoz, a global leader in off-patent (generic and biosimilar) medicines, announced that the European Medicines Agency (EMA) has accepted the marketing authorization applications (MAA) for proposed biosimilar denosumab for regulatory review. The two applications include all indications covered by the reference medicines Prolia (denosumab) and Xgeva (denosumab), respectively, for treating a variety of conditions, including osteoporosis in postmenopausal women and in men at increased risk of fractures, treatment-induced bone loss, prevention of skeletal related complications in cancer that have spread to the bone, and giant cell tumour of the bone.
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