BRIEF — Kyowa Hakko has copy of its own biologic approved in Japan

Observers are unsure whether to call it a ‘biosame’ or an ‘authorized biosimilar’, but Japanese drugmaker Kyowa Hakko Kirin has had a copy of its own biologic approved in its home country.

The company has received manufacturing and marketing approval for a darbepoetin alfa injection syringe, calling it an authorized version of NESP, the product that Kyowa Kirin had approved in Japan in 2007 for the treatment of anemia in adult chronic kidney disease patients.

Marketing will be carried out by the group’s recently-founded subsidiary, Kyowa Kirin Frontier.