On February 13, 2025, the FDA approved Samsung Bioepis Co., Ltd.’s denosumab biosimilars, OSPOMYV™ (denosumab-dssb; 60 mg pre-filled syringe) and XBRYK™ (denosumab-dssb; 120 mg vial), referencing Amgen’s PROLIA® and XGEVA®, respectively. The FDA also granted a provisional determination for both OSPOMYV and XBRYK’s interchangeability designation. These approvals make Samsung the second company to receive FDA approval for a denosumab biosimilar, joining Sandoz.
Denosumab is a RANK ligand (RANKL) inhibitor that is used to treat bone loss. The FDA approved OSPOMYV™ for treatment of postmenopausal women with osteoporosis, treatment to increase bone mass in men with osteoporosis, treatment of glucocorticoid-induced osteoporosis in men and women, treatment to increase bone mass in men receiving androgen deprivation therapy for nonmetastatic prostate cancer, and treatment to increase bone mass in women receiving adjuvant aromatase inhibitor therapy for breast cancer. The FDA approved XBRYK™ for the prevention of skeletal-related events in patients with multiple myeloma and in patients with bone metastases from solid tumors, treatment of adults and skeletally mature adolescents with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity, and for the treatment of hypercalcemia of malignancy refractory to bisphosphonate therapy.
Samsung also announced last week that the European Commission has granted marketing authorization to their denosumab biosimilars, OBODENCE™ (denosumab-dssb; 60 mg pre-filled syringe) and XBRYK™ (denosumab-dssb; 120 mg vial), again referencing Amgen’s PROLIA® and XGEVA®, respectively.