Japan approves first darbepoetin alfa biosimilar

Biosimilars/News | Posted 14/09/2018 post-comment0 Post your comment

Japan-based Kyowa Hakko Kirin announced on 16 August 2018 that it had gained Japanese approval for its darbepoetin alfa biosimilar.


Darbepoetin alfa is a synthetic form of erythropoietin. It stimulates erythropoiesis (increases red blood cell levels) and is used to treat anaemia, commonly associated with chronic renal failure and cancer chemotherapy.

Kyowa Hakko Kirin’s product (darbepoetin alfa injection syringe [KKF]) is a biosimilar of the company’s own originator product, Nesp (darbepoetin alfa), which the company co-developed with Amgen (which markets its own product in the US and Europe as Aranesp). Nesp was initially approved in Japan in July 2007 and Kyowa Hakko Kirin’s biosimilar is being launched as an ‘authorized version’ of Nesp.

The news marks Japan’s first approval of a darbepoetin alfa biosimilar in the country [1].

Kyowa Hakko Kirin’s biosimilar has been approved for the same indications as for Nesp, i.e. for the treatment of anaemia in adult chronic kidney disease patients on/ not on dialysis. The biosimilar will be jointly sold by Kyowa Hakko Kirin and Kyowa Kirin Frontier, which was established in January 2017 to promote the health and well-being of the people in Japan.

Related article
Biosimilars of darbepoetin alfa

1.  GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Japan [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Sep 14]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Japan

Permission granted to reproduce for personal and non-commercial use only. All other reproduction, copy or reprinting of all or part of any ‘Content’ found on this website is strictly prohibited without the prior consent of the publisher. Contact the publisher to obtain permission before redistributing.

Copyright – Unless otherwise stated all contents of this website are © 2018 Pro Pharma Communications International. All Rights Reserved.

Source: Kyowa Hakko Kirin

comment icon Comments (0)
Post your comment
Related content
Most viewed articles
About GaBI
Home/About GaBI Posted 06/08/2009
EU guidelines for biosimilars
EMA logo 1 V13C15
Home/Guidelines Posted 08/10/2010