Dong-A ST announced on October 1 that Japanese chemical research institute SKK filed with the Japanese Ministry of Health, Labor and Welfare for permission to manufacture and sell DA-3880, a biosimilar for the treatment of anemia, whose production technology was transferred from Dong-A ST.
DA-3880 is a biosimilar of Darbepoetin-α, a persistent red blood cell hematopoietic stimulant developed jointly by Amgen of the United States and Kyowa Hakko Kirin of Japan. Dong-A ST developed the biosimilar and exported its technology to SKK in January 2014. The biosimilar is used for the treatment of anemia in patients with chronic renal failure and anemia from chemotherapy.
SKK received the technology from Dong-A ST and has been promoting development of biosimilars in Japan. It conducted phase 1 clinical trial in 2015 and has been conducting phase 3 clinical tests to confirm whether the efficacy of DA-3880 is equal to that of original medicine in patients with chronic renal failure.
If the Japanese Ministry of Health, Labor and Welfare approves the biosimilar, Dong-A ST will export the finished products to SKK, which will sell them in Japan. The Japanese government usually gives sales approval within 12 months after application.
"We will work closely with SKK to ensure that DA-3880 can be successfully settled in Japan," said an official from Dong-A ST.