Samsung Bioepis has secured marketing approval in Korea for Xbryk, its biosimilar to Amgen’s bone cancer drug Xgeva. This wraps up its two-pronged denosumab program, with Xgeva and Prolia biosimilars now cleared in the country.

The Ministry of Food and Drug Safety nod marks the company’s 11th domestic approval. It follows its April greenlight for Obodence, a biosimilar to Prolia, Amgen’s blockbuster used in hormone-induced bone loss and postmenopausal osteoporosis.

With this approval, Samsung Bioepis has brought to market every biosimilar in its global pipeline that has completed clinical trials.

Amgen’s original denosumab products -- Prolia and Xgeva -- earned $6.6 billion globally in 2024, with the Korean market accounting for an estimated 187 billion won ($135 million).

Denosumab’s bifurcated use case has made it a high-value target for biosimilar developers. While Prolia is prescribed to strengthen bone in patients undergoing hormone therapy for prostate or breast cancer, Xgeva is used to prevent fractures in those with bone metastases from solid tumors or multiple myeloma and to treat rare conditions like unresectable giant cell tumors.

Samsung Bioepis followed Amgen’s lead, pursuing indication-specific approvals rather than bundling both products under a single label. With Xbryk cleared, the company has matched its U.S. and EU regulatory wins at home, completing its denosumab task across all three major markets.

“With both Obodence and Xbryk now approved in Korea, we can offer patients cost-effective options for bone-related diseases,” said Jung Byoung-in, Samsung Bioepis’ vice president of regulatory affairs, in a statement on Friday. “This adds meaningful momentum to our efforts to increase access.”