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Korean Pharmaceutical Companies Eyeing Japanese Biosimilar Market
Entering Biosimilar Niche Market
Korean Pharmaceutical Companies Eyeing Japanese Biosimilar Market
  • By Choi Moon-hee
  • October 19, 2018, 11:44
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In 2014, Dong-A ST signed a contract with SKK of Japan for the export of “DA-3880," a biosimilar to Nesp.

As the global biosimilar market keeps growing, Korean pharmaceutical companies that have been focusing on traditional drugs are turning their attention to biosimilars. Unlike the newly established large biosimilar companies, these companies follow a strategy to target Japan, which is a niche market, instead of the U.S. or European markets.

According to the pharmaceutical industry on October 18, Chong Kun Dang Pharm., Dong-A ST and CJ Healthcare are pushing to launch their biosimilars to "Nesp" in Japan. Nesp is a second-generation anemia treatment co-developed by Amgen of the U.S. and Kyowa Hakko Kirin of Japan. While the first-generation treatment had to be injected three times a week, Nesp can be injected one or two times a week.

In April, Chong Kun Dang Pharm. signed a contract with a Japanese company to export “CKD-11101,” a Nesp biosimilar it has developed. It has applied for sales approval from the Japanese Ministry of Health, Labour and Welfare (MHLW) after completing clinical trials earlier this month.

Dong A Pharmaceutical also filed an application with MHLW for sales approval of its biosimilar in September through the Japanese company Sanwa Kagaku Kenkyusho (SKK). Donga-st signed a contract with SKK in 2014 for the export of Nesp biosimilar “DA-3880."

CJ Healthcare, which exported the technology of Nesp biosimilar "CJ-40001" to Japan’s YL Biologics in September last year, is planning to apply for sales approval to the MHLW as soon as the ongoing Phase III clinical trials are completed. The patent of Nesp will expire in August 2019.

In addition, LG Chemical launched the Enbrel biosimilar “Eucept” in the Japanese market in May.

The reason traditional pharmaceutical companies focus on the Japanese market is that they can secure sufficient profits in a relatively less competitive market. In case of Nesp, sales in the Japanese market amounted to 600 billion won, which is one fifth of global sales of 3 trillion won last year. Moreover, the Japanese government is encouraging the launch of biosimilars due to the increasing greying population in Japan.

An official in the pharmaceutical industry said, "In Japan, it is possible to supply products with relatively small production facilities, and the distribution cost is also low because it is relatively close to the US or Europe. That is why traditional pharmaceuticals with relatively little capital are trying to enter Japanese and Taiwanese markets."