Two treatments for bone diseases by Samsung Bioepis have obtained product approval from the U.S. Food and Drug Administration (FDA) and the European Commission.
The treatments for bone diseases Prolia and Xgeva (ingredient name denosumab) developed by global pharmaceutical company Amgen are biopharmaceuticals. Depending on the dosage and administration cycle, they are classified as osteoporosis treatment (Prolia) and treatments for giant cell tumors (Xgeva). Last year, the combined sales of the two products reached 10 trillion won.
Samsung Bioepis obtained product approval for each indication, just like the original drugs. The Prolia biosimilar was approved under the name 'Ospomyv™' in the United States and 'Obodence™' in Europe, while the Xgeva biosimilar was approved under the name 'Xbryk™' in both the United States and Europe.
With this, Samsung Bioepis has secured 10 biosimilar products in the United States and 11 in Europe. Jeong Byeong-in, executive director of Samsung Bioepis, said, "We are pleased to have received approvals for both the Prolia and Xgeva biosimilars in the United States and Europe," and noted, "We will continue to strive to meet the unmet needs for medications for patients worldwide through the development of biosimilars in various disease areas."