Chong Kun Dang Pharmaceutical said Sunday that it has become the first company in the world to receive sales approval for a second-generation anemia biosimilar, CKD-11101 (Ingredient: Darbepoetin- alfa).
Approved by the Ministry of Food and Drug Safety, the company plans to release the biosimilar in the domestic market next year.
CKD-11101 is the first biosimilar version of novel erythropoiesis stimulating protein (NESP) co-developed by Japan’s Kyowa Hakko Kirin and Amgen, a U.S. company. It treats anemia of chronic disease associated with cancer. Compared to the first generation of drugs the treatment significantly reduced the frequency of drug administration by using genetic engineering techniques.
Chong Kun Dang also plans to speed up the entry into the Japanese market of 500 billion won ($445.63 million) and the global market of 3 trillion won.
Starting in 2014, Chong Kun Dang has been preparing to enter the global market by acquiring patents for the drug in nine countries, including the U.S., Europe, and Japan.
The company has already exported the drug to a pharmaceutical company in Japan and applied for sales approval for its anemia biosimilar to the Japanese Ministry of Health, Labor and Welfare in October.