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Celltrion applied for approval of anticancer drug biosimilar ‘Herzuma’ in Japan


- The second application for sales permission in Japanese market after Remsima, Japan's first antibody biosimilar

- Reach out 450 billion KRW worth of original drug products market work in corporation with NIPPON KAYAKU

[12, April, 2017] Celltrion announced that the company submitted the application for sales approval to Japanese Ministry of Health, Labour and Welfare on 11th to enter the Japanese market for anticancer antibody biosimilar Herzuma(CT-P6, INN: Trastuzumab) that the company itself developed.


Herzuma is an anticancer antibody biosimilar used to treat breast cancer and gastric cancer. Its original product is ‘Herceptin’, which is developed and sold by Roche. The size of the original pharmaceutical market in Japan is estimated to be around 450 billion KRW, and Celltrion is aiming to launch in 2018 after approval of the sale of Herzuma..


Nippon kayaku, a partner for distribution of Herzuma, has maintained a strong partnership with Celltrion and has shown strength in the market for anticancers. Also, the company has sold Remsima of Celltrion, the first antibody biosimilar introduced to Japan, since the end of 2014, and has continued to increase market share steadily.


Celltrion official said “Celltrion, which is ready to hit the global market, including Europe, is responding closely to partner companies for Herzuma to settle early in Japanese market as well, When Herzuma is introduced to Japan, we expect positive effects on increasing market shares of Celltrion products including through enhancing awareness of the overall biosimilar.” 

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