Submission of Application for Marketing Approval of CT-P13 Infliximab Biosimilar Monoclonal Antibody, in Japan

On September 11, 2013, Nippon Kayaku Co., Ltd. (Head Office: Tokyo; President: Akira Mandai; hereafter referred to as “Nippon Kayaku”) submitted an application for marketing approval of the Infliximab biosimilar monoclonal antibody (development code: CT-P13) which was developed jointly with Celltrion, Inc. and Celltrion Healthcare Co., Ltd. (together the Celltrion Group; Head Office: Incheon, South Korea; CEO & Chairman: Jung Jin Seo) to the Ministry of Health, Labour and Welfare in Japan.

CT-P13 is a biosimilar of the Infliximab monoclonal antibody that has played an important role in treatment of rheumatoid arthritis and other autoimmune diseases, and has already been marketed in 6 countries including South Korea. Approval for marketing in Europe was also received on August 26, 2013. Nippon Kayaku began development of this biosimilar in November 2010 following the conclusion of a cooperation agreement with the Celltrion Group.

CT-P13 is the second biosimilar for Nippon Kayaku following Filgrastim BS Inj, which was marketed earlier this year. In the field of autoimmune diseases, since 2001 Nippon Kayaku has marketed Saligren^® Cap. 30 mg, a drug for treatment of dry-mouth symptoms among patients suffering from Sjögren’s syndrome. With the marketing of the Infliximab biosimilar monoclonal antibody, we expect to make an even greater contribution to patients with rheumatoid arthritis and other autoimmune diseases, their families and medical professionals.
[Reference material—Profile of Celltrion, Inc.]

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