Samsung Bioepis has received approval from the US Food and Drug Administration (FDA) for two denosumab biosimilars, Ospomyv (denosumab-dssb; SB16; 60 mg pre-filled syringe) and XBRYK (denosumab-dssb; SB16; 120 mg vial).
These biosimilars reference Amgen’s Prolia and Xgeva, respectively. The FDA has also granted a provisional determination for their interchangeability designation.
Ospomyv has been approved for multiple osteoporosis-related indications, including treatment in postmenopausal women and men at high risk of fractures.
It is also indicated for individuals undergoing glucocorticoid therapy, men receiving androgen deprivation therapy for non-metastatic prostate cancer, and women receiving aromatase inhibitor therapy for breast cancer.
XBRYK has been authorised for the prevention of skeletal-related events in patients with multiple myeloma or bone metastases from solid tumours.
It is also indicated for treating adults and skeletally mature adolescents with giant cell tumours of the bone that are unresectable or where surgical resection may cause severe morbidity. Additionally, it has been approved for the treatment of hypercalcaemia of malignancy refractory to bisphosphonate therapy.
The FDA’s decision was based on analytical, non-clinical, and clinical data, including a Phase 1 study that confirmed pharmacokinetic equivalence between SB16 and EU- and US-sourced reference denosumab in healthy male participants. A Phase 3 trial demonstrated equivalent efficacy and comparable safety, immunogenicity, pharmacokinetics (PK), and pharmacodynamics (PD) in postmenopausal osteoporosis patients.
Samsung Bioepis vice president and regulatory affairs team leader Byoungin Jung said: “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.
“This achievement underscores our commitment to healthcare innovation through biosimilars and our mission to meet the growing needs in critical therapeutic areas.”
Separately, the European Commission (EC) has granted marketing authorisation for Obodence (60 mg pre-filled syringe) and XBRYK (120 mg vial), referencing Prolia and Xgeva, respectively.
The EC approval was supported by similar clinical data, confirming comparable efficacy and safety.
