Filgrastim BS and Lantus BS Approval- Encouraging uptake and a lesson to fast track JP approval based on Ex-Japan data!
Remicade biosimilar “NK” – A slow start does not pull back NK in starting PhIII for Herceptin BS in Japan
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The launch of Remicade biosimilar in Dec-2014 in the Japan pharma market demonstrated its changing regulatory environment; it is faster than U.S. in adapting to biosimilar use. After nine years of continuous efforts by the JP government to promote increased use of generics (start ..."
With three products and eight players already in market – Japan biosimilar market will enter new phase of biosimilars with first ‘mab’ approval expected in 2014. This approval (Remicade- FY03/13A sales ¥73.5, infiximab from Nippon Kayaku by YE 14) w ..."
¥200b worth of biologic products is going off patent by 2015 and this value exceeds ~ ¥500b if we include products that will see their patent expiries by 2021 in Japan. There are a number of reasons to believe that follow-on-biologics ..."