Two darbepoetin alfa biosimilars submitted to Japan’s PMDA

Biosimilars/News | Posted 12/10/2018 post-comment0 Post your comment

Two South Korean firms have announced that they have submitted applications for approval of their proposed darbepoetin alfa biosmilars to Japan’s medicines regulatory agency, the Pharmaceuticals and Medical Devices Agency (PMDA).

Anaemia 2 V13J18

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.

Korea-based Dong-A ST (Dong) announced on 1 October 2018 that it had, together with Japan-based Sanwa Kagaku Kenkyusho (SKK), filed for Japanese regulatory approval of DA‑3880, a proposed darbepoetin alfa biosimilar. Dong and SKK signed a licensing agreement back in January 2014, giving SKK the technology to develop DA‑3880. The company carried out a phase I clinical trial in 2015 and has been conducting phase III clinical trials to confirm that the efficacy of DA‑3880 is equal to that of the originator biological in patients with chronic renal failure.

The pair expect to receive a regulatory decision within 12 months of their filing and, if the biosimilar is approved, SKK will handle distribution of the product in Japan.

Then on 5 October 2018, South Korean drugs firm Chong Kun Dang Pharmaceutical (CKDP) announced that it had submitted an application for approval of its proposed darbepoetin alfa biosimilar, CKD‑11101, to Japan’s PMDA. In April 2018, CKDP made a deal with the Japanese unit of an American pharmaceutical firm. If approved, CKDP intends to export the biosimilar to the Japanese unit, which will be responsible for sales of CKD‑11101 in Japan.

The two products are proposed biosimilars of Kyowa Hakko Kirin’s 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. In August 2018, Kyowa Hakko Kirin also gained approval for an ‘authorized’ biosimilar ‘version’ of Nesp [1], the first darbepoetin alfa biosimilar to be approved in the country.

Worldwide sales of darbepoetin alfa are estimated to be US$3 billion, with sales in Japan reaching Yen 50 billion (approx. US$441 million).

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1.  GaBI Online - Generics and Biosimilars Initiative. Japan approves first darbepoetin alfa biosimilar []. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Oct 12]. Available from:

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Source: Business Korea, Dong-A ST, Chong Kun Dang, The Korea Herald, YonHapNews

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