Approval of Prolia and Xgeva Biosimilars
Samsung Bioepis announced on the 16th that it has obtained marketing approvals for two biosimilar products of the bone disease treatments Prolia & Xgeva (active ingredient denosumab) from the U.S. Food and Drug Administration (FDA) and the European Commission (EC), respectively.
Prolia and Xgeva are biopharmaceuticals developed by the global pharmaceutical company Amgen. Depending on the dosage and administration cycle, they are classified as treatments for osteoporosis (Prolia) and giant cell tumor of bone and other conditions (Xgeva). Last year, the combined annual global sales of these two products reached $6.599 billion (approximately 9.7 trillion KRW).
Samsung Bioepis obtained marketing approvals for each indication, identical to the original drugs. The Prolia biosimilar was approved under the product name 'Ospomyv™' in the U.S. and 'Obodence™' in Europe, while the Xgeva biosimilar was approved under the product name 'Xbryk™' in both the U.S. and Europe.
With this, Samsung Bioepis has secured 10 biosimilar products in the U.S. and 11 in Europe, solidifying its position as a leading company in the global biosimilar industry.
In addition to existing treatments for autoimmune, oncology, ophthalmology, and rare diseases, the company has expanded its product portfolio to include the bone disease field, once again demonstrating its global-level research, development, and regulatory capabilities.
Jung Byung-in, head of Samsung Bioepis's Regulatory Affairs (RA) team, stated, "We will continue to strive to address the unmet needs of patients worldwide by developing biosimilars across various disease areas."
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