Samsung Bioepis Secures Korean Approval for Denosumab Biosimilar XBRYK, Completing Global Regulatory Trifecta
核心洞察
Samsung Bioepis (搜索) received Korean regulatory approval for XBRYK, a biosimilar to Amgen's bone cancer drug XGEVA, used to prevent fractures in patients with bone metastases and treat rare bone tumors.
The approval follows earlier Korean approval of OVODENS (搜索), a biosimilar to Amgen's PROLIA for osteoporosis treatment, giving Samsung access to a combined global market worth $6.599 billion annually.
Samsung has now secured regulatory approval for both denosumab biosimilars across all three major markets including the United States and Europe.
Samsung Bioepis (搜索) announced it has obtained product approval from Korea's Ministry of Food and Drug Safety for XBRYK, a biosimilar version of Amgen's bone disease treatment XGEVA. The approval marks a significant milestone for the South Korean biopharmaceutical company, completing regulatory approval across all three major global markets.
Expanding Access to Bone Disease Treatments
XBRYK contains denosumab and is designed to prevent skeletal complications in patients with bone metastasis cancer (搜索) and treat conditions such as unresectable giant cell tumors (搜索). The biosimilar targets the same patient population as Amgen's original XGEVA, offering an alternative treatment option for bone cancer patients.
This approval follows Samsung Bioepis (搜索)'s earlier success in April when it received Korean approval for OVODENS (搜索), a biosimilar to Amgen's PROLIA. PROLIA is used for endocrine treatments including postmenopausal osteoporosis (搜索), while XGEVA focuses on tumor-related bone diseases.
Significant Market Opportunity
The combined global sales of PROLIA and XGEVA reached $6.599 billion in the previous year, equivalent to approximately 9.7 trillion won. Within Korea specifically, the prescription market for these denosumab-based products is valued at about 187 billion won, representing a substantial commercial opportunity for Samsung Bioepis (搜索).
"It is significant that both OVODENS (搜索) and XBRYK will be able to expand opportunities to treat diseases at a more reasonable cost to patients with bone disease by obtaining product approval in Korea following the global market," said Jeong Byeong-in, managing director of Samsung Bioepis (搜索) Regulatory Affairs.
Global Regulatory Success
Samsung Bioepis (搜索) has now secured marketing approval for both denosumab biosimilars across the United States, Europe, and Korea. In the U.S., the FDA approved OSPOMYV (denosumab-dssb; 60 mg pre-filled syringe) and XBRYK (denosumab-dssb; 120 mg vial) as biosimilars to PROLIA and XGEVA respectively. The European Commission granted similar marketing authorization for OBODENCE (denosumab-dssb; 60 mg pre-filled syringe) and XBRYK (denosumab-dssb; 120 mg vial).
Expanding Korean Portfolio
With the XBRYK approval, Samsung Bioepis (搜索) has increased its total number of licensed products in Korea to 11. The company notes that all biosimilar pipelines that have completed global clinical trials can now be commercialized in the Korean market, positioning the company to leverage its research and development investments across multiple therapeutic areas.
The approval strategy mirrors that of the original drugs, with Samsung Bioepis (搜索) pursuing separate product approvals for each indication, ensuring comprehensive coverage of the denosumab treatment landscape in Korea.