Samsung Bioepis said Thursday it has received domestic sales approval for Samfenet, a trastuzumab biosimilar (Original: Herceptin), from the Ministry of Food and Drug Safety (MFDS).
Herceptin is one of the most purchased biomedicine with an estimated 7.8 trillion won ($6.9 billion) in sales.
It has applications for early and metastatic breast cancer and metastatic gastric cancer. The company did not confirm its release schedule, however.
“Our company plans to start sales after choosing a company to sell the drug and confirming the price of the drug,” Samsung Bioepis 삼성바이오에피스 said in a statement.
With the approval of Samfenet, the company has expanded its biosimilar products from autoimmune disease to anticancer. It currently owns three autoimmune disease biosimilars -- Benepali, Flixabi and Imraldi -- and one anticancer biosimilar.
Samfenet is also under review for marketing authorization by the European Medicines Agency.