South Korean biopharma companies, such as Chong Kun Dang and Dong-A ST, move to launch biosimilars in Japan despite some trade tensions, as their therapies will be managed and distributed by Japanese firms. For example, both firms have applied for their respective Nesp biosimilars late 2018. Nesp is an erythropoietin drug, which is a catalyst for red blood cell production and is used for anemia treatment as well as for chronic renal failure and some anticancer treatments.
The original branded drug comes from a joint venture between Amgen and Japan’s Kyowa Hakko Kirin. Their patent in Korea expired in 2015 and will expire in the U.S. in 2024. The worldwide estimated market for Nesp is $3 billion, reports The Korea Herald.
Tensions but Trade
Although Japan and South Korea apparently are mired in trade tensions involving Tokyo’s restrictions against tech materials exported to Korea, it is believed that the pending decision from the Japanese Ministry of Health, Labor and Welfare’s Pharmaceutical and Medical Device Agency will not be based on politics. It helps that the Koreans have licensed their IP to local Japanese firms.
Bloomberg reports that Japan’s merging of trade and politics may put its Prime Minister in the spotlight, and they must compromise as robust trade and commerce truly lead to better tomorrows.
Korean Firms Localize in Japan
The South Korean biotech firms are licensing-out their therapies to local Japanese companies to manage the affairs in that country for those biosimilars. For example, Dong-A ST licensed out DA-3880 to Japan’s Sanwa Kagaku Kenkyusho (SKK) back in 2014. It was SKK that applied for the approval of DA-3880 with the Japanese regulatory authorities.
Moreover, Chong Kun Dang inked an exclusive deal with the Japanese arm of an unidentified American Pharma company in 2018 for its Nesp biosimilar CKD-11101 entry into Japan for clinical trials, application for sales approval and exclusive sales in Japan.
CJ Healthcare, another Korean venture, is conducting clinical trials for its Nesp biosimilar CJ-40001 via Japanese partner YL Biologics, which it licensed its IP to in September 2017, reports Lim Jeong-yeo of the Korea Herald.