Samsung Bioepis Receives Domestic Approval for Prolia Biosimilar

Ovodens, an Osteoporosis Treatment,
Received Marketing Authorization in the US and Europe in February

Samsung Bioepis Headquarters. Photo by Samsung Bioepis

Samsung Bioepis announced on the 6th that it has received domestic marketing authorization from the Ministry of Food and Drug Safety for 'Ovodens,' a treatment for osteoporosis and other conditions.

Ovodens is a biosimilar (biopharmaceutical generic) of 'Prolia,' a treatment developed by Amgen for osteoporosis and bone loss in patients with prostate cancer and breast cancer.

Prolia recorded global sales of approximately KRW 6.5 trillion (USD 4.374 billion) last year, with the domestic market size reaching about KRW 174.9 billion.

Following the acquisition of marketing authorization for the Prolia biosimilar under the product names 'Ospomib' in the United States and 'Ovodens' in Europe last February, Samsung Bioepis can now expand treatment options for patients with bone diseases domestically through this approval.

With this, Samsung Bioepis has increased its biosimilar product portfolio to a total of 10 products in South Korea, including existing treatments for autoimmune tumor diseases, ophthalmic, rare blood, and kidney diseases, as well as bone disease treatments.

Jung Byung-in, Executive Director of Samsung Bioepis, stated, "With the approval of Ovodens, we have expanded opportunities to treat domestic patients with bone diseases at reasonable costs. We will continue to strive to enhance patient benefits through biosimilars and create social value such as reducing health insurance finances."