On February 16, the FDA approved Samsung Bioepis’ biologics license application for SB16, its denosumab biosimilar candidate. Dubbed Ospomyv for the treatment of postmenopausal women with osteoporosis (reference product Prolia), and Xbryk (denosumab-dssb) for the treatment of bone complications of oncology disorders (reference product Xgeva), this is the second denosumab biosimilar approval in the US.
Ospomyv’s approved indications include:
- Treatment of osteoporosis in postmenopausal women who have a high risk for fracture
- Treatment of osteoporosis in men with a high risk for fracture (to increase bone mass)
- Treatment of glucocorticoid-induced osteoporosis in men and women at high risk for fracture
- Increasing bone mass in men receiving androgen-deprivation therapy for nonmetastatic prostate cancer at high risk for fracture
- Increasing bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer
Xbryk’s indications include:
- 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 hypercalcemia of malignancy refractory to bisphosphonate therapy
In a press release, Byoungin Jung, Vice President and Regulatory Affairs Team Leader at Samsung Bioepis, stated, “The FDA approval of OSPOMYV and XBRYK marks a key step in improving patient access and alleviating treatment cost for patients with osteoporosis and cancer-related bone loss in the US. By providing quality-proven biosimilars, we are helping to address a critical healthcare need and reduce the burden of skeletal fractures that impact patients’ quality of life.”
Samsung Bioepis has not yet named a marketing partner in the US for their launch of Ospomyv and Xbryk. The company also announced European Commission approval of these biosimilars on the same date.
Sandoz’s Jubbonti/Wyost gained FDA approval in March 2024, with the interchangeability designation. The FDA provided Samsung Bioepis with a provisional interchangeability designation, meaning that once the exclusivity period expires, both Ospomyv and Xbryk will be considered interchangeable with the reference products as well.
The main patent for Prolia and Xgeva expires this month, and several denosumab biosimilar launches are expected, starting in May. Amgen, which produces the reference products, reported combined US revenues for Prolia and Xgeva in 2024 of about $4.4 billion. At least four other manufacturers are expecting FDA decisions on their denosumab biosimilars in 2025, and up to 11 manufacturers have disclosed denosumab biosimilar candidates.