FDA and EMA green light Samsung Bioepis’ Prolia and Xgeva copies

South Korean biosimilars company Samsung Bioepis has announced that the US Food and Drug Administration (FDA) and European Commission (EC) have approved Ospomyv (denosumab-dssb; 60mg pre-filled syringe) and Xbryk (denosumab-dssb; 120mg vial).

These biosimilars reference the Amgen (Nasdaq: AMGN) biologics Prolia and Xgeva, respectively. The FDA has also granted a provisional determination for both Ospomyv and Xbryk's interchangeability designation.

Ospomyv, referencing Prolia, has been approved for postmenopausal women with osteoporosis at high risk for fracture, to increase bone mass in men with osteoporosis at high risk for fracture and for glucocorticoid-induced osteoporosis in men and women at high risk for fracture.