Number of biosimilars approved by PMDA Japan 2010-2019
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.
