License application for proposed biosimilar denosumab to treat osteoporosis and related conditions is accepted by FDA.- Sandoz
Sandoz, a global leader in off-patent (generic and biosimilar) medicines, announced that the FDA has accepted its Biologics License Application (BLA) for proposed biosimilar denosumab.
The application includes all indications covered by the reference medicines Prolia (denosumab) and Xgeva (denosumab) 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 has spread to the bone, giant cell tumor of the bone, and treatment of hypercalcemia of malignancy refractory to bisphosphonate therapy.
In the US alone, more than 10 million adults over age 50 are estimated to have osteoporosis, of whom more than 80% are women. It is predicted that one in two of these women and one in four men will have an osteoporosis-related fracture in their lifetimes. Osteoporosis-related fractures may lead to diminished quality of life, disability, and even death.
The denosumab patents in the EU expired in 2022 and the estimated expiry of patents in the US is February 2025.
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