First approval of generic dry powder inhaler drug products in Japan
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SHORT COMMUNICATION
First approval of generic dry powder inhaler drug products in Japan Ryosuke Kuribayashi 1 & Aya Myoenzono 2
# Controlled Release Society 2020
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. Keywords First approval . Generic . Dry powder inhaler drug products . Japan
Background In March 2016, the Ministry of Health, Labour and Welfare (MHLW) published the basic principles of bioequivalence (BE) evaluations for generic dry powder inhaler (DPI) drug products in Japan [1]. Basic principles were formulated to promote the development of effective and safe generic DPI drugs. One of the reasons for the introduction of these principles was because the generic version of the DPI products was not in the scope of the existing “Guideline for Bioequivalence Studies of Generic Products” that was published in 2012 [2]. Based on this document, the Pharmaceuticals and Medical Devices Agency (PMDA) advises generic companies on effective development through consultation meetings. The Key points This article introduces the first approval of generic DPI drug products based on public information. The PMDA generally requires data from in vitro tests, pharmacokinetic studies, and pharmacodynamic or clinical endpoint bioequivalence studies. This product is the first generic version of Symbicort Turbuhaler. * Ryosuke Kuribayashi [email protected] 1
2
PMDA generally requires data from in vitro tests, pharmacokinetic (PK) studies, and pharmacodynamic (PD) or clinical endpoint studies for generic drug development [3].
Data package for the generic version of Symbicort Turbuhaler Introduction Generic DPI drug products have not been approved since 2018, after the basic principles were reported, although the MHLW approved the first generic version of Symbicort Turbuhaler in 30- and 60-dose pack sizes in February 2019. This product emits 160 μg of budesonide and 4.5 μg of formoterol fumarate dihydrate per delivered dose. It was developed by the Toa Pharmaceutical Company, Nihon Generic Company, and Nipro Corporation. These products were approved for the same indications as the original products (i.e., asthma and chronic obstructive pulmonary disease). The package insert, interview form, and document of the BE data r
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