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Number of biosimilar medicines approved by the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan from 2010 to 2019

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Release date

March 2020

Region

Japan

Survey time period

2010 to 2019; the Japanese fiscal year starts on April 1 of the stated year and ends on March 31 of the following year

Citation formats

Number of biosimilars approved by PMDA Japan 2010-2019

Published by A. Minhas, May 20, 2020
In 2019, a total of eight new biosimilar medicines were approved by the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan, representing a peak in the last decade. Biosimilars refer to medical drugs that are equivalent or highly similar in quality to the biologic medical products that were already approved in the country. PMDA functions as a regulatory agency for pharmaceutical products and medical devices, working together with the health ministry in Japan.
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