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].

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

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