Dong-A ST said that Sanwa Kagaku Kenkyusho (SKK), its Japanese partner, has received sales approval for DA-3880, Aranesp (Ingredient: darbepoetin alfa) biosimilar with indications for anemia, from Japan's Ministry of Health, Labour and Welfare.
|Dong-A ST headquarters in Yongdu-dong, eastern Seoul|
The Korean company signed a licensing-out agreement on the development and sale of the DA-3880 in Japan with SKK in January 2014, and the latter started conducting clinical trials from 2015.
In 2016, SKK performed a phase 3 clinical trial to confirm the efficacy and safety of DA-3880 compared to the original in patients with chronic renal failure in Japan. Based on the results of the trial, the Japanese company received approval for nine volumes of the drug – 5㎍, 10㎍, 15㎍, 20㎍, 30㎍, 40㎍, 60㎍, 120㎍, and 180㎍.
With the approval, Dong-A ST plans to export the finished products to SKK through DM Bio, a biosimilar company in Dong-A Socio Group, and SKK will market the drug in Japan.
DM Bio received a good manufacturing practice certification for its production facility from Japan Pharmaceuticals and Medical Devices Agency earlier this month.
Aranesp, DA-3880's original product, co-developed by Amgen and Kyowa Kirin, is a synthetic form of erythropoietin. It stimulates erythropoiesis and treats anemia, commonly associated with chronic renal failure and cancer chemotherapy.
The drug has an annual sales goal of $3 billion worldwide and 50 billion yen in Japan.
"Japan, which has entered an aging society, is expected to see a significant increase in its biosimilar market as the need to decrease medical expenses has come to light," a company official said. "It is expected that DA-3880 will successfully settle in the Japanese market based on economic benefits and the same efficacy and safety as the original."
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