• J Pharm Sci · Mar 2018

    Review

    Current Japanese Regulatory Systems for Generics and Biosimilars.

    • Ryosuke Kuribayashi and Kenji Sawanobori.
    • Office of Generic Drugs, Pharmaceuticals and Medical Devices Agency, 3-3-2, Kasumigaseki, Chiyoda-ku, Tokyo 100-0013, Japan. Electronic address: kuribayashi-ryosuke@pmda.go.jp.
    • J Pharm Sci. 2018 Mar 1; 107 (3): 785-787.

    AbstractCurrently, biosimilar products are being actively developed around the world. One reason for this is the expiry of patents of original biopharmaceutical products with an extremely large market share because the biosimilar companies need to avoid infringing patents. A representative example of this is biosimilar versions of monoclonal antibodies. In Japan, the Ministry of Health, Labour and Welfare is promoting the use of biosimilar products because the market share of such products is currently extremely low compared with that of generic products. The Pharmaceuticals and Medical Devices Agency is responsible for reviewing generic and biosimilar products in Japan. However, no comparison of review systems for generics and biosimilars in Japan has been published. A more detailed understanding of review systems is important for using generic and biosimilar products. This article presents the current Japanese review systems for generic and biosimilar products and also the future challenges to facilitate the better regulation of both types of product.Copyright © 2018 American Pharmacists Association®. Published by Elsevier Inc. All rights reserved.

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