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.
Number of biosimilar medicines approved by the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan from 2010 to 2019
Approved year
Number of products
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OPIR. (March 15, 2020). Number of biosimilar medicines approved by the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan from 2010 to 2019 [Graph]. In Statista. Retrieved July 22, 2024, from https://www.statista.com/statistics/1118558/japan-pmda-approved-biosimilars/
OPIR. "Number of biosimilar medicines approved by the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan from 2010 to 2019." Chart. March 15, 2020. Statista. Accessed July 22, 2024. https://www.statista.com/statistics/1118558/japan-pmda-approved-biosimilars/
OPIR. (2020). Number of biosimilar medicines approved by the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan from 2010 to 2019. Statista. Statista Inc.. Accessed: July 22, 2024. https://www.statista.com/statistics/1118558/japan-pmda-approved-biosimilars/
OPIR. "Number of Biosimilar Medicines Approved by The Pharmaceuticals and Medical Devices Agency (Pmda) in Japan from 2010 to 2019." Statista, Statista Inc., 15 Mar 2020, https://www.statista.com/statistics/1118558/japan-pmda-approved-biosimilars/
OPIR, Number of biosimilar medicines approved by the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan from 2010 to 2019 Statista, https://www.statista.com/statistics/1118558/japan-pmda-approved-biosimilars/ (last visited July 22, 2024)
Number of biosimilar medicines approved by the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan from 2010 to 2019 [Graph], OPIR, March 15, 2020. [Online]. Available: https://www.statista.com/statistics/1118558/japan-pmda-approved-biosimilars/