Approvals

The US Food and Drug Administration (FDA) has approved Samsung Bioepis’ biosimilars referencing Amgen’s bone disease therapy denosumab.

The regulator has approved Ospomyv (denosumab-dssb) and Xbryk (denosumab-dssb) for all indications covered by Amgen’s Prolia and Xgeva, respectively.

Ospomyv has been authorised to treat certain patients with osteoporosis and glucocorticoid-induced osteoporosis at high risk for fracture, men at high risk for fracture receiving androgen deprivation therapy for non-metastatic prostate cancer and women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer.

Meanwhile, Xbryk has been approved to prevent skeletal-related events in patients with multiple myeloma or bone metastases from solid tumours, as well as to treat certain adults and skeletally mature adolescents with a giant cell tumour of bone, and patients with hypercalcaemia of malignancy refractory to bisphosphonate therapy.

A biosimilar, according to the FDA, is a biological product that is highly similar to one already approved in the US. This means patients can expect the same safety and effectiveness from the biosimilar as they would from the reference product, but may potentially benefit from lower healthcare costs.

Byoungin Jung, vice president and regulatory affairs team leader at Samsung Bioepis, 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.”