< Relevant articles > Please go to PubMed here. Kuribayashi, R., Nakano, A., Hariu, A., Kishioka, Y. & Honda, F. Historical Overview of Regulatory Approvals and PMDA Assessments for Biosimilar Products in Japan During 2009-2022. Bio Drugs 37, 443-51 (2023). 10.1007/s40259-023-00605-6 < Backgrounds > biosimilar products, we decided to publish basic matters related to the regulations of biosimilar products in international scientific journals as a first step. < Outline> < Impact on RS, expectations > in Japan and further promote their development in Japan. In addition, it is expected that the deeper understanding of the regulations in Japan and other countries will enable us to consider challenges in the Japanese regulations and to make contribute to earlier access of biosimilar products that are cheaper and comparable to the original biological products to patients. Office of Cellular and Tissue-based Products, Ryosuke Kuribayashi 20 We would like to disseminate the Japanese regulations to the world. Since no articles touched on the regulations of We hope that this paper will facilitate a deep understanding of data required for approval application of biosimilar products more specific discussions in promoting international harmonization of regulations in the future. In the end, we hope to This article describes about the data package for quality, nonclinical, and clinical studies required for biosimilar products in Japan based on the "Guideline for Ensuring Quality, Safety, and Efficacy of Biosimilars" (February 4, 2020) and various Q & As, with presenting the backgrounds and awareness of problems at that time. The article also shows the approval trend of biosimilar products by presenting the number of biosimilars approved by December 2022 in Japan and the rate of each type of biological products such as antibodies and hormones. In 2022, of the 32 biosimilar products, 16 (50.0%) were antibody drugs, indicating that many approved biosimilar products were antibody drugs. (Source: BioDrugs. 2023 Jul; 37 (4): 443-451; the position of numbers is partially changed in Figure 4) Historical Overview of Regulatory Approvals and PMDA Assessments for Biosimilar Products in Japan During 2009-2022
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