Samsung Bioepis announced on the 30th that it has received marketing authorization for the osteoporosis treatment 'Xgeva (active ingredient denosumab)' biosimilar 'Xbryk®' from the Ministry of Food and Drug Safety.
Xgeva is an osteoporosis treatment developed by Amgen in the United States, used alongside the endocrine therapy 'Prolia' for postmenopausal osteoporosis and for preventing skeletal complications in patients with bone metastasis as well as in treating giant cell tumors. Xgeva and Prolia had a combined global revenue of $6.599 billion (9.7 trillion won) last year, with a prescription value of about 187 billion won in the domestic market.
Samsung Bioepis has been approved for the same diseases as the original drug. Following the approval of the Prolia biosimilar 'Obodence®' in April, the approval of the Xgeva biosimilar means the company has secured two products containing denosumab in Korea, the United States, and Europe. This brings the total number of products that the company has received domestic marketing authorization for to 11, enabling all biosimilar products that completed global clinical trials to be commercialized domestically.
Jeong Byeong-in, the Head of Team at Samsung Bioepis, noted, 'It is significant that we have obtained marketing authorization for both Obodence and Xbryk® in Korea, following the global market, as it expands opportunities for osteoporosis patients to treat their disease at a more reasonable expense.'