The new Tokyo-based firm will market the product – code named KRN321 – in Japan and other Asian markets.
The drug has been filed for review in several countries according to an R&D pipeline update included in Kyowa Hakko Kirin’s 2016 report.
Kyowa Hakko Kirin said the new subsidiary was its response to “changes in the social environment surrounding healthcare in Japan and the diversification of the needs thereof, and to meet social demands for medical cost containment.”
The Japanese Government has been trying to curb spending on drugs since 2007.
The approach has been to encourage the use and production of generic small molecule medicines and – since the introduction of specific regulatory guidelines in 2009 – biosimilar products.
Kyowa Hakko Kirin - which co-developed Aranesp with Amgen – sells the red blood cell booster as Nesp in a number of countries in Asia.
A spokesman for the Japanese firm told us “Kirin-Amgen is licensor, and both Kyowa Hakko Kirin and Amgen are licensees.”
According to Kyowa’s 2016 financial results, Nesp generated revenue of ¥56.3 ($497m) in 2016, which is down 2% on the previous year.
The firm predicts that the drug will see sales of ¥57.2bn in 2017.
The Kyowa Hakko Kirin spokesman confirmed the product is identical to NESP, telling us Frontier plans to file it with Japanese regulators but has not decided on a name of the product.
He also stressed that the firm is referring to the product as an “Authorized version of NESP,” because the term “biosimilar” is not defined under Japanese regulations.