Dong-A ST (Chairman Eom Dae-sig) announced on October 1 that Sanwa Kagaku Kenkyusho (SKK, President Hata Katsumi) had submitted its application for authorization to market DA-3880, a biosimilar of ‘Darbepoetin-α’, a sustained erythropoiesis-stimulating agent, to the Ministry of Health, Labor and Welfare of Japan.

In January 2014, Dong-A ST and SKK of Japan signed a licensing-out agreement for the development and sales of DA-3880 in Japan.

SKK began pursuing the development of the product within Japan with the start of the Phase I clinical trials in 2015, and has been performing the Phase III clinical trials of DA-3880 on patients with chronic renal failure since 2016 in order to confirm that its efficacy and safety are equivalent to those of the original drug.

Under the agreement, Dong-A ST will export the finished drug product to SKK after receiving the marketing authorization, and SKK will be responsible for its marketing and sales in Japan. Marketing authorization is usually handled by the Ministry of Health, Labor and Welfare of Japan within 12 months of receiving an application.

DA-3880 is a biosimilar of Darbepoetin-α, a sustained erythropoiesis-stimulating agent co-developed by Amgen of the USA and Kyowa Hakko Kirin of Japan. It is used to treat anemia in patients with chronic renal failure and anemia caused by chemotherapy. Its worldwide sales currently stand at $3 billion, with sales in Japan reaching 50 billion yen.

An official from Dong-A ST said, “As Japan becomes a super-aged society, the market for biosimilars with high economic efficiency is expected to increase significantly in the future, as the need to reduce medical costs increases. Dong-A ST will work closely with Sanwa Kagaku Kenkyusho to ensure that DA-3880 can be successfully deployed in Japan, and, based on its success in Japan, we will make efforts to develop biopharmaceuticals that can be used in the global market in the future.”