Chong Kun Dang has won an approval from Japan's Ministry of Health, Labor and Welfare to manufacture and sell the world's first second-generation anemia treatment biosimilar, "Nesbell."
In April last year, Chong Kun Dang signed a contract with the Japanese subsidiary of U.S. global pharmaceutical company Mylan N.V. to conduct clinical trials for Nesbel's authorization in Japan, grant product licenses, and sell products exclusively, and applied for approval to the Japanese ministry in October.
Chong Kun Dang will export Nesbell's finished products to the Japanese subsidiary of Mylan, while the Japanese company will release the products in December after undergoing a drug price decision process.
It is a second-generation, sustainable product that uses genetic engineering technology to significantly reduce the frequency of drug administration to improve patients' convenience, and launched the product in September after having already received an approval for an item license in Korea.
Chong Kun Dang is set to enter the global market based on Nesbell's legal patents acquired in nine countries, including the United States, Europe and Japan, starting at home in 2014.
"Nesbell is the world's first NESP biosimilar and the company's first biomedical drug to be approved for manufacturing and selling in Japan. We are planning to speed up our advance into the 3.6 trillion won global market starting with the 550 billion won market in Japan," a company official said.
