DA-3880 (darbepoetin alfa biosimilar) / Noritsu Koki, Dong-A, Suzuken - LARVOL DELTA

A Study in Healthy Volunteers to Compare the Profiles of DA-3880 and EU Sourced ARANESP® (Amgen) (clinicaltrials.gov) - P1; N=64; Completed; Sponsor: Dong-A ST Co., Ltd.; Recruiting ➔ Completed

Trial completion • Anemia • Hematological Disorders

Dong-A ST seeks approval for Aranesp biosimilar in Japan (The Investor) - "Korean pharmaceutical firm Dong-A ST said on Oct. 1 its co-developer Sanwa Kagaku Kenkyusho has sought approval from the Japanese health regulator for its biosimilar version of Amgen’s red blood cell booster Aranesp....The drug candidate DA-3880 is a copy version of Aranesp, co-developed by Kyowa Hakko Kirin and Amgen, a treatment of anemia associated with chronic renal failure or caused by chemotherapy. "

Japanese regulatory • Anemia

Dong-A ST's Aranesp biosimilar gets nod in Japan (Korea Biomedical Review) - "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."

Japanese regulatory