MITSUBISHI TANABE – Remicade Biosimilar in Japan: Rapid Movements in Competitive Landscape!

Date: 2015-07

On September 11th, Nippon Kayaku (NK) has filed BLA for Remicade biosimilar in Japan (CT-P13, partnered with Celtrion). If approved, it will be the first mab biosimilar to be launched in the Japan. NK鈥檚 BLA filing is based on the EU clinical data provided by Celtrion and some clinical studies done in Japan. Based on reported positive PhIII data of CT-P13 in European RA patients against originator Infliximab (Table 2- CT-P13 Global PhIII data), we expect it to get an approval in Japan within standard review timeline and launch by FY2014. Currently, Remicade is growing at ~7% YoY and posted ~楼73b in 03/13

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