Samsung Bioepis announced on the 6th that it has received domestic product approval for the treatment of bone disease Obodence® (ingredient name denosumab) from the Ministry of Food and Drug Safety.
Obodence is a biosimilar (a copy of a biopharmaceutical) for Prolia, a treatment for osteoporosis and bone loss in prostate cancer and breast cancer patients developed by the global pharmaceutical company Amgen. Prolia recorded sales of $4.374 billion (about 6.5 trillion won) last year. The domestic market size is about 174.9 billion won.
Samsung Bioepis first obtained product approvals in the U.S. and Europe in February under the product names 'Ospomyv™' and 'Obodence™' respectively. With this approval, the domestic biosimilar product portfolio has expanded to a total of 10 types.
This approval in Korea has also expanded the treatment options for domestic patients. Biosimilars have the same level of therapeutic effect as the original drug, but they are less expensive. Samsung Bioepis entered into a joint sales agreement with Hanmi Pharmaceutical on the 18th of last month and has decided to collaborate on the marketing and sales of Obodence in Korea.
Jung Byeong-in, Senior Vice President and Head of Team at Samsung Bioepis's Regulatory Affairs department, noted, 'With the approval of Obodence, we have expanded the opportunities to treat domestic patients at a reasonable expense,' and added, 'We will continue to strive for social value creation, such as enhancing patient benefits through biosimilars and alleviating health insurance costs.'