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Bioequivalence Evaluations of Generic Dry Powder Inhaler Drug Products: Similarities and Differences Between Japan, USA, and the European Union

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Abstract

In Japan, the development of generic oral dry powder inhaler (DPI) drug products for marketing approval has recently increased. The Pharmaceuticals and Medical Devices Agency (PMDA) considers the required data for each drug product in the consultation meeting. However, guidelines for DPI drug products have been published by the US Food and Drug Administration and the European Medicines Agency. Recently, the basic principles of bioequivalence evaluations of generic DPI drug products were published in March 2016 by the Ministry of Health, Labour and Welfare. The document mainly outlines the current understanding regarding the bioequivalence evaluations of generic DPI drug products based on knowledge from PMDA consultation meetings. In this review, we compared the bioequivalence evaluations of DPI drug products among Japan, USA, and the European Union and discuss future development of generic DPI drug products in Japan.

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Authors and Affiliations

  1. Office of Generic Drugs, Pharmaceuticals and Medical Devices Agency, 3-3-2 Kasumigaseki, Chiyoda-ku, Tokyo, 100-0013, Japan

    Ryosuke Kuribayashi, Toru Yamaguchi, Hanaka Sako, Tomoko Takishita & Kazunori Takagi

Authors
  1. Ryosuke Kuribayashi
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  2. Toru Yamaguchi
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  3. Hanaka Sako
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  4. Tomoko Takishita
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  5. Kazunori Takagi
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Correspondence to Ryosuke Kuribayashi.

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No external funding was used in the preparation of this manuscript.

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Ryosuke Kuribayashi, Toru Yamaguchi, Hanaka Sako, Tomoko Takishita, and Kazunori Takagi declare that they have no conflict of interest that might be relevant to the contents of this manuscript.

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The views expressed in this article are those of the authors and do not necessarily reflect the official views of the Pharmaceuticals and Medical Devices Agency. Please note that in this article some proper nouns in English, such as titles of basic principles, were provisional translations from Japanese literature by the authors.

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Kuribayashi, R., Yamaguchi, T., Sako, H. et al. Bioequivalence Evaluations of Generic Dry Powder Inhaler Drug Products: Similarities and Differences Between Japan, USA, and the European Union. Clin Pharmacokinet 56, 225–233 (2017). https://doi.org/10.1007/s40262-016-0438-8

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  • DOI: https://doi.org/10.1007/s40262-016-0438-8

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