April 16, 2024

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South Korean biopharma firms Chong Kun Dang andDong-A ST expect to launch their biosimilars in Japan without a headwind, despite escalating trade strife, as their drugs will be represented by Japanese partner firms.

The erythropoietin drug Nesp, for which the patent expires in Japan this year, is a catalyst for red blood cell production and can treat anemia from chronic renal failure or anticancer treatments.

The original drug is a joint venture of US’ Amgen and Japan’s Kyowa Hakko Kirin. Its patent expired in Korea in 2015 and will expire in the US in 2024. The worldwide market for Nesp is estimated to be in excess of $3 billion.

Both Chong Kun Dang and Dong-A ST applied for their respective Nesp biosimilars in October 2018 and are awaiting the launch of sales in the second half of this year through their partner firms.

The Korean firms believe that the pending approval from the Japanese Ministry of Health, Labor and Welfare’s Pharmaceuticals and Medical Devices Agency will not be involved in the trade spat involving Tokyo’s restrictions against tech materials exported to Korea. The belief is strengthened in that the applications for approval were made by Japanese firms that the drugs were licensed to.

Dong-A ST licensed out DA-3880 to Japan’s Sanwa Kagaku Kenkyusho in 2014. SKK applied for DA-3880’s approval in October 2018.

“The application for approval was made through our Japanese partner, and therefore our concerns that the trade tension will affect the drug is low,” Dong-A ST representative said.

“It’s true the industry is carefully assessing the developing situation with Japan,” a representative from Dong-A ST told The Korea Herald, “But what’s more worrisome is the excessive concerns that are building up that weigh down on the industry prospects.”

Chong Kun Dang signed an exclusive deal with the Japanese arm of an unidentified American pharma firm in April 2018 for its Nesp biosimilar CKD-11101’s clinical trials, application for sales approval and exclusive sales in Japan.

”Normally the process at the PMDA takes a year, and so far we have not had any issue,“ a Chong Kun Dang representative told The Korea Herald.

”We expect to begin sales of the drug as soon as we acquire approval, which would be in the second half of this year,“ the representative said.

Another Korean firm, CJ Healthcare, is also carrying out phase 3 clinical trials for its Nesp biosimilar CJ-40001 through Japanese partner YL Biologics, to which it licensed in September 2017.

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

By Lim Jeong-yeo/The Korea Herald (kaylalim@heraldcorp.com)