FDA Accepts Sandoz BLA for Biosimilar Referencing Amgen’s Prolia and Xgeva

The FDA has accepted Sandoz’s Biologics License Application (BLA) for its biosimilar candidate denosumab to treat osteoporosis in postmenopausal women and in men at increased risk of fractures, treatment-induced bone loss, giant cell tumor of the bone, hypercalcemia of malignancy refractory to bisphosphonate therapy and to prevent skeletal related complications in cancer that has spread to the bone.

These indications are the same as those covered by Amgen’s Prolia (denosumab) and Xgeva (denosumab).

The submission included data from a phase 1/3 study confirming that the biosimilar matches the reference medicine for pharmacokinetics, pharmacodynamics, efficacy, safety and immunogenicity.