The FDA has approved two biosimilars of Prolia and Xgeva developed by Organon and Shanghai Henlius Biotech. Bildyos (denosumab-nxxp) 60 mg and Bilprevda (denosumab-nxxp) 120 mg are injection products approved for the same indications as the reference products.

Bildyos is a RANK ligand (RANKL) inhibitor that references Prolia and is indicated for postmenopausal women with osteoporosis at high risk for fracture, to increase bone mass in men with osteoporosis at high risk for fracture, for the treatment of glucocorticoid-induced osteoporosis in men and women at high risk for fracture.

Bilprevda is a RANKL inhibitor that references Xgeva and is indicated for the prevention of skeletal-related events in certain patients with multiple myeloma and bone metastases from solid tumors, giant cell t

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