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Japan Biosimilars - ¥200b Worth of Biologic Products Going Off Patent by 2015
Date:2/12/2013

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Biogeneric opportunity, it's likely profitability vs. risk profile
Development cost of biosimilars vs. small molecules
Price difference vs. small molecules and DPC hospitals business are key drivers
-Co-pay Slabs in Japan
-Saving through biosimilar use
-Pricing of key biologics in Japan

Regulatory Guidelines: Stringent Enough to Restrict Scope of Import
Korosho guidelines- Key difference vs. US, EU
JP requirement of
-Reference Product
-Interchangeability/Substitution
-Pharmacovigilance
-PMS for biosimilar

Select Japanese Companies venturing into biogeneric space - Their strategy and Pipeline

JCR Pharmaceuticals

Meiji Seika Pharma

Fuji Film Kyowa Kirin Biologics

Nichi Iko

Mochida

Nipro Pharma

Yoshindo

Nippon Kayaku


SOURCE Bharat Book Bureau
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