USA – FDA approves first interchangeable biosimilars to Prolia and Xgeva to treat certain types of osteoporosis and prevent bone events in cancer

FDA approved Jubbonti (denosumab-bbdz) injection as an interchangeable biosimilar to U.S.-licensed Prolia (denosumab), and Wyost (denosumab-bbdz) injection as an interchangeable biosimilar to U.S.-licensed Xgeva (denosumab).

These products bind to RANKL (receptor activator of nuclear factor kappa beta ligand), blocking its ability to bind to its receptor, a protein called RANK. Inhibition of the RANKL/RANK interaction helps prevent bone cells called osteoclasts from breaking down bone in the body. This is the first interchangeable biosimilar for a RANKL inhibitor…