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. 2020 Oct;10(5):1517-1519.
doi: 10.1007/s13346-020-00817-1.

First approval of generic dry powder inhaler drug products in Japan

Ryosuke Kuribayashi  1 , Aya Myoenzono  2
Affiliations

First approval of generic dry powder inhaler drug products in Japan

Ryosuke Kuribayashi et al. Drug Deliv Transl Res. 2020 Oct.

Abstract

The Japanese Ministry of Health, Labour and Welfare (MHLW) published the basic principles of bioequivalence evaluations for generic dry powder inhaler (DPI) drug products in March 2016. The basic principles were formulated to promote the development of effective and safe generic DPI drugs. Based on this document, the Pharmaceuticals and Medical Devices Agency (PMDA) advises generic companies on effective development through consultation meetings. The PMDA generally requires data from in vitro tests, pharmacokinetic studies, and pharmacodynamic or clinical endpoint studies for generic drug development. The MHLW approved the first generic version of the Symbicort Turbuhaler in 30- and 60-dose pack sizes in February 2019. This article presents the concrete data on the first approval of generic DPI drug products based on public information. Graphical abstract.

Keywords: Dry powder inhaler drug products; First approval; Generic; Japan.

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References

    1. MHLW. Basic principles on the bioequivalence evaluation for the generic DPI drug products. 2016. https://www.pmda.go.jp/files/000210452.pdf#search=%27%E5%90%B8%E5%85%A5%... Accessed 6 Jan 2020 (In Japanese).
    1. MHLW. Guideline for Bioequivalence Studies of Generic Products. 2020. https://www.pmda.go.jp/files/000234565.pdf Accessed 22 May 2020 (In Japanese).
    1. Kuribayashi R, Yamaguchi T, Sako H, Takishita T, Takagi K. Bioequivalence evaluations of generic dry powder inhaler drug products: similarities and differences between Japan, USA, and the European Union. Clin Pharmacokinet. 2017;56:225–33. - DOI
    1. Package insert for BudeForu Dry Powder Inhaler. https://www.pmda.go.jp/PmdaSearch/iyakuDetail/ResultDataSetPDF/480018_22... Accessed 22 May 2020 (In Japanese).
    1. Document of bioequivalence study for BudeForu Dry Powder Inhaler. http://www.nihon-generic.co.jp/medical/search/files/BUDEF00_BE.pdf#searc... Accessed 1 July 2020 (In Japanese).

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