Sandoz Denosumab BLA Accepted by FDA

The US FDA has accepted a Biologics License Application (BLA) from Sandoz for a proposed denosumab biosimilar. In its press-release, Sandoz stated that 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.”  Included in the BLA are data from the Phase I/III ROSALIA study, for which Sandoz announced positive results in September 2022.  Per the press release, denosumab is a human monoclonal antibody designed to bind to RANKL, which is an activator of osteoclasts (cells involved in breaking down bone tissue). Binding to and inhibiting RANKL decreases production and activity of osteoclasts, contributing to the therapeutic effect of denosumab.