On Feb. 28, 2025, the FDA approved Celltrion’s denosumab biosimilars, STOBOCLO® (denosumab-bmwo; 60 mg/mL injection) and OSENVELT® (denosumab-bmwo; 70 mg/mL injection), referencing Amgen’s PROLIA® and XGEVA®, respectively. These approvals make Celltrion the third company to receive FDA approval for a denosumab biosimilar, joining Samsung and Sandoz.
Denosumab is a RANK ligand (RANKL) inhibitor that is used to treat bone loss. The FDA approved STOBOCLO® to treat postmenopausal women with osteoporosis, increase bone mass in men with osteoporosis, treat glucocorticoid-induced osteoporosis in men and women, increase bone mass in men receiving androgen deprivation therapy for nonmetastatic prostate cancer, and increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer. The FDA approved OSENVELT® to prevent skeletal-related events in patients with multiple myeloma and in patients with bone metastases from solid tumors, treat 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 treat hypercalcemia of malignancy refractory to bisphosphonate therapy.
Celltrion announced that STOBOCLO® and OSENVELT® are expected to be available on the U.S. market in June 2025, in accordance with their settlement agreement with Amgen.