TOKyO, Japan I July 4, 2014 I Nippon Kayaku Co., Ltd. (Head Office: Tokyo; President: Akira Mandai; hereafter referred to as “Nippon Kayaku”) today announced that Nippon Kayaku has obtained the marketing approval of Infliximab BS for I.V. Infusion 100mg 「NK」 (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). This product is a Monoclonal Antibody Biosimilar, firstly approved in Japan.

Infliximab BS for I.V. Infusion 100mg 「NK」 is a biosimilar of the Infliximab monoclonal antibody that has played an important role in treatment of Rheumatoid Arthritis, Inflammatory Bowel Disease and other autoimmune diseases, and has already been marketed in 25 countries including South Korea and Europe. Nippon Kayaku began development of this biosimilar in November 2010 following the conclusion of a cooperation agreement with the Celltrion Group.

Infliximab BS for I.V. Infusion 100mg 「NK」 is the second biosimilar for Nippon Kayaku following Filgrastim BS Inj, which was marketed last year. In the field of autoimmune diseases, since 2001 Nippon Kayaku has marketed Saligren® Cap. 30mg, a drug for treatment of dry-mouth symptoms among patients suffering from Sjögren’s syndrome. With the marketing of Infliximab BS for I.V. Infusion 100mg 「NK」, we expect to make an even greater contribution to patients with Rheumatoid Arthritis and Inflammatory Bowel Disease, their families and medical professionals.

SOURCE: Nippon Kayaku