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Korean firms to launch biosimilars in Japan despite trade tensions Posted 16/08/2019

Despite increasing trade tensions between Japan and Korea, two Korean firms have confirmed that they intend to move ahead with the launch of their darbepoetin alfa biosimilars in Japan in the second half of 2019.

Japan and South Korea are experiencing trade tensions involving Tokyo’s restrictions against export of high-tech materials, critical for manufacturing semiconductors and display screens, to South Korea.  Despite this, South Korean biologicals makers Chong Kun Dang (CKD) and Dong-A ST (Dong) still expect to launch their darbepoetin alfa biosimilars in Japan during 2019.

The products are biosimilars 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). The patent on Nesp expires in August 2019.

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.

The South Korean companies believe that the pending approval from the Japanese Ministry of Health, Labour and Welfare’s Pharmaceuticals and Medical Devices Agency will not be involved in the ongoing trade tensions. This belief is based on the fact that they have both made collaboration agreements with Japanese companies to launch the products in the country.

Dong signed a licensing agreement back in January 2014 with Japan-based Sanwa Kagaku Kenkyusho (SKK), giving SKK the technology to develop DA‑3880, its proposed darbepoetin alfa biosimilar. In April 2018, CKD made a deal with the Japanese unit of an American pharmaceutical firm, to which it intends to export its proposed biosimilar CKD‑11101 for sales in Japan [1].

In October 2018, both Dong and SKK, and CKD and its Japanese unit, filed for Japanese regulatory approval of DA‑3880 and CKD‑11101, respectively [1].

Another Korean firm, CJ Healthcare, is also carrying out phase III clinical trials for its candidate darbepoetin alfa biosimilar CJ-40001 via Japanese partner YL Biologics, with which it made a licensing agreement in September 2017.

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

On 17 July 2019, Korea and Japan also held talks on bilateral collaboration on the latest pharmaceutical and medical device regulation trends, medical trial regulations, regenerative medicine trends, pharma price trends, in-vitro diagnostic devices regulation and the sharing of information.

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1. GaBI Online - Generics and Biosimilars Initiative. Two darbepoetin alfa biosimilars submitted to Japan’s PMDA [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Aug 16]. Available from:

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Source: Business Korea, CNBC, The Korean Herald, TrialSiteNews

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