FDA Approves Fourth Denosumab Biosimilar

The US Food and Drug Administration (FDA) has approved denosumab-bnht (Conexxence/Bomyntra), manufactured by Fresenius Kabi, for all indications of the reference product denosumab (Prolia/Xgeva).

The biosimilar will launch in the United States in June 2025 as part of a global settlement with Amgen, which manufactures the reference product. 

The higher dosage of denosumab-bnht (Bomyntra; 120 mg/1.7 mL) is approved for:

• 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
• 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

The lower dosage (Conexxence; 60 mg/mL) is approved for treatment:

• Of postmenopausal women with osteoporosis at high risk for fracture
• To increase bone mass in men with osteoporosis at high risk for fracture
• Of glucocorticoid-induced osteoporosis in men and women at high risk for fracture
• To increase bone mass in men at high risk for fracture receiving androgen deprivation therapy for nonmetastatic prostate cancer
• To increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer

This is the fourth pair of denosumab biosimilars approved by the agency. Denosumab-bddz (Wyost [high dose]/Jubbonti [low dose]), developed by Sandoz, was the first to receive approval in March 2024 . In February 2025, the FDA approved Samsung Bioepis’ denosumab-dssb (Xbryk [high dose]/Ospomyv [low dose]) followed by Celltrion’s denosumab-bmwo (Osenvelt [high dose]/Stoboclo [low dose]) in early March. 

Denosumab-bmwo is also expected to launch in June 2025, while Samsung Bioepis and Sandoz have not announced a release timeline for their denosumab biosimilars.