Organon and Shanghai Henlius Biotech, Inc. announced on September 2, 2025, that the U.S. Food and Drug Administration (FDA) has approved BILDYOS (denosumab-nxxp) injection 60 mg/mL and BILPREVDA (denosumab-nxxp) injection 120 mg/1.7 mL. These are biosimilars to PROLIA (denosumab) and XGEVA (denosumab), respectively, approved for all indications of their reference products.
BILDYOS is indicated for treating postmenopausal women and men with osteoporosis at high risk for fracture, glucocorticoid-induced osteoporosis, and increasing bone mass in men receiving androgen deprivation therapy or women receiving aromatase inhibitor therapy. BILPREVDA is indicated for preventing skeletal-related events in certain patients with multiple myeloma and bone metastases from solid tumors, giant cell tumor of bone, and hypercalcemia of malignancy.
These approvals are based on a comprehensive data package demonstrating that BILDYOS and BILPREVDA are highly similar to their reference products with no clinically meaningful differences in safety, purity, and potency. Organon holds exclusive global commercialization rights for these biosimilars, except for China, under a 2022 license and supply agreement with Henlius, further expanding Organon's biosimilars portfolio in the U.S.
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