FDA accepts Sandoz biosimilar denosumab BLA

Sandoz, the generics and biosimilars business unit of Swiss pharma giant Novartis (NOVN: VX) that is soon to be spun out, today announced that the US Food and Drug Administration (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.

Both brands are marketing by US biotech giant Amgen (Nasdaq: AMGN), with Prolia (for osteoporosis) generating full-year 2022 global sales of $3.63 billion, up 12%, and Xgeva (for bone cancer) recording $2.01 billion, unchanged.