CKD Pharma’s darbepoetin alfa biosimilar launched in Japan

Biosimilares/Novedades | Posted 18/01/2019 post-comment0 Post your comment

On 4 December 2018, South Korean drugmaker Chong Kun Dang Pharmaceutical (CKD Pharma) announced that it had received approval for its second-generation anaemia biosimilar, CKD‑11101 (darbepoetin alfa).


The company submitted the application for approval of its proposed darbepoetin alfa biosimilar, CKD‑11101, to Japan’s MHLW in October 2018 [1]. The product is a biosimilar of Kyowa Hakko Kirin’s Nesp (darbepoetin alfa). The originator biological, Nesp, was 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. In August 2018, Kyowa Hakko Kirin also gained approval for an ‘authorized’ biosimilar ‘version’ of Nesp [2], the first darbepoetin alfa biosimilar to be approved in the country.

CKD Pharma estimates the Japanese market for darbepoetin alfa to be worth Won 500 billion (US$445.63 million) and the global market to be worth Won 3 trillion (US$2.6 billion). The company says it ‘plans to speed up the entry’ of its darbepoetin alfa biosimilar in both markets. It also says that it has been ‘preparing to enter the global market by acquiring patents for the drug in nine countries, including the US, Europe and Japan’.

CKD Pharma says that it has already exported the drug to a pharmaceutical company in Japan in preparation for marketing in the country. This company is presumed to be Japan-based Fuji Pharma, with whom CKD Pharma made a licensing deal in February 2016 for darbepoetin alfa [3].

Related article
Biosimilars of darbepoetin alfa

1. GaBI Online - Generics and Biosimilars Initiative. Two darbepoetin alfa biosimilars submitted to Japan’s MHLW []. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Jan 18]. Available from:
2. GaBI Online - Generics and Biosimilars Initiative. Japan approves first darbepoetin alfa biosimilar []. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Jan 18]. Available from:
3. GaBI Online - Generics and Biosimilars Initiative. Fuji Pharma gains rights to darbepoetin alfa biosimilar in Japan []. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Jan 18]. Available from:

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 © 2019 Pro Pharma Communications International. All Rights Reserved.

Source: Korea Biomedical Review

comment icon Comments (0)
Post your comment
Related content
La FDA aprueba el biosimilar pegfilgrastim Stimufend
Biosimilares/Novedades Posted 07/10/2022
Most viewed articles
Sobre GaBI
INICIO/Sobre GaBI Posted 06/08/2009
EU guidelines for biosimilars
EMA logo 1 V13C15
INICIO/Directrices Posted 08/10/2010