Novartis announced that FDA has accepted Sandoz’s biologics license application (BLA) for the proposed biosimilar denosumab. The application features all indications covered by the reference medicines Prolia (denosumab) and Xgeva (denosumab) for treating multiple conditions, such as osteoporosis in postmenopausal women and in men at increased risk of fractures, treatment-induced bone loss, prevention of skeletal-related complications in cancer that has spread to the bone, giant cell tumor of the bone, and treatment of hypercalcemia of malignancy refractory to bisphosphonate therapy.
