Regulatory filing for biosimilar Herceptin in Japan

An application for marketing approval of the “trastuzumab (genetical recombinant) preparation” biosimilar monoclonal antibody (CT-P6) has been submitted to Japan’s Ministry of Health, Labor and Welfare by Japanese drugmaker Nippon Kayaku (TYO: 4272).

Developed jointly with South Korea’s Celltrion (Kosdaq: 068270), CT-P6 is a biosimilar preparation of trastuzumab, a monoclonal antibody that plays an important role in the treatment of HER2 positive breast cancer and gastric cancer, that is marketed by Roche (ROG: SIX) as Herceptin and generated sales of around $6.7 billion for the Swiss pharma giant last year.

Nippon Kayaku began development of this biosimilar in November 2010 following the conclusion of a cooperation agreement for development and marketing of CT-P6 with the Celltrion group. Celltrion, which gained Korean approval for its Herceptin biosimilar in 2014, has submitted its marketing approval application in Europe.

CT-P6 is the second monoclonal antibody biosimilar for Nippon Kayaku following Infliximab BS for IV Infusion 100mg “NK.” With a goal of early launch of this product, we expect to make a significant contribution to cancer patients, their families and medical professionals,” said Nippon Kayaku.