Ryosuke Kuribayashi
14PUBLICATIONS
1CO-AUTHORS
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Publications (14)
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|Sep 19, 2025
Survey on the Role of Comparative Efficacy Studies Required for Biosimilar Monoclonal Antibody Approval in Japan to Justify the Quality Attribute Differences Between Biosimilars and Their Reference Products Based on the Pharmaceuticals and Medical Devices Agency (PMDA) Assessments.Kanoko Goto, Aya Hariu, Ryosuke Kuribayashi
|Aug 13, 2025
Consideration of the biosimilar drug lag and loss among Japan, the USA, and the EU.Aya Hariu, Yuka Saino, Ryosuke Kuribayashi
|Jun 09, 2025
Regulation for the Bioequivalence Evaluation of Generic Topical Dermatological Drug Products in Japan.Miho Kasuga, Kimika Kuwana, Ryosuke Kuribayashi
|Jun 04, 2025
The 100th Monoclonal Antibody Product is Approved in Japan.Aya Hariu, Yukiko Shirahata, Kayo Shinohara
|Feb 14, 2025
Efforts of the Pharmaceuticals and Medical Devices Agency of Japanese regulatory agency in supporting biosimilar development and disseminate information.Ryosuke Kuribayashi, Aya Hariu, Yuka Saino
|Nov 12, 2024
Trend Analysis of Regulatory Approvals for Generics and Biosimilars in Japan: 15 Years of PMDA During Fiscal Years 2009-2023.Ryosuke Kuribayashi, Kanoko Goto, Takumi Ogawa
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