Trastuzumab biosimilar submitted for approval in Japan

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Trastuzumab biosimilar submitted for approval in Japan

Biosimilares/Novedades | Posted 14/04/2017 0 Post your comment

Japan-based Nippon Kayaku announced on 11 April 2017 that it had submitted an application for its trastuzumab biosimilar, CT-P6, to the Ministry of Health, Labour and Welfare (MHLW) in Japan.

The product, which was developed jointly with Celltrion, is a biosimilar of Roche’s breast cancer blockbuster Herceptin (trastuzumab).

CT-P6 is the second monoclonal antibody biosimilar that Nippon Kayaku has brought to Japan. The company received MHLW approval for its biosimilar Infliximab BS in July 2014 [1]. Both biosimilars were developed as part of Nippon Kayaku’s November 2010 cooperation agreement with Celltrion for development and marketing of several biosimilars.

Nippon Kayaku now has three biosimilars filed or approved. The company also started marketing Filgrastim BS in 2013. The filgrastim biosimilar was produced in collaboration with development partner Teva Pharmaceutical Industries [2].

References
1. GaBI Online - Generics and Biosimilars Initiative. Biosimilar infliximab receives approval in Japan and Turkey [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Apr 14]. Available from: www.gabionline.net/Biosimilars/News/Biosimilar-infliximab-receives-approval-in-Japan-and-Turkey
2. GaBI Online - Generics and Biosimilars Initiative. Japan approves second biosimilar G-CSF [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Apr 14]. Available from: www.gabionline.net/Biosimilars/News/Japan-approves-second-biosimilar-G-CSF

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Source: Nippon Kayaku