What is Biosimilar?
A biosimilar is a product comparable with regard to quality, safety, and efficacy to a biotechnology-derived product already approved in Japan as a pharmaceutical with new active ingredients (original biopharmaceutical), which is developed by a different marketing authorization holder.
Approved Biosimilar Products
List of Approved Products[38.8KB]
Related Guidelines, Notifications, and Information
The following English translations of Japanese guideline and notification are intended to be a reference material to provide convenience for users. In the event of inconsistency between the Japanese originals and the translations, the former shall prevail.
Guideline and notification on ensuring quality, safety, and efficacy for Biosimilars
- Handling of Japanese Data for Confirmation of Comparability of Biosimilars to the Original Biopharmaceuticals (Early Consideration) [81.7KB]
September 19, 2025 - Questions and Answers (Q&A) on Guideline for Ensuring the Quality, Safety, and Efficacy of Biosimilars[200KB]
January 25, 2024
PSB/PED Administrative Notice
February 4, 2020
PSEHD/PED Notification No. 0204-1
February 14, 2013
PFSB/ELD Notification No. 0214-1
Learning Videos: Review
- Review of Biosimilars - PMDA-ATC Learning Video - YouTube
You will be transferred to an external website (YouTube : Pmda Channel) by clicking the image.
Presentations
- Fukushima S. Regulatory Trends of Antibody Therapeutics in Japan. Global Bio Conference 2025. September 2025[796KB]
- Tanaka K. Current Regulation on Biosimilar in Japan. International Regulatory Science Forum 2025. March 2025[1.15MB]
- Otaki N. Regulatory and Scientific Considerations for Biosimilars in Japan. The 12th Joint Conference of Taiwan and Japan on Medical Products Regulation. October 2024[1.0MB]
- Shirahata Y. Current regulation on CMC of Biopharmaceuticals in Japan. Global Bio Conference 2024. September 2024[1.53MB]
- Kuribayashi R. Regulatory Experience and Considerations to Date from PMDA. IPRP Biosimilar Workshop. September 2023[155KB]
Publications
- Goto K, Hariu A, Kuribayashi R. Survey on the Role of Comparative Efficacy Studies Required for Biosimilar Monoclonal Antibody Approval in Japan to Justify the Quality Attribute Diferences Between Biosimilars and Their Reference Products Based on the Pharmaceuticals and Medical Devices Agency (PMDA) Assessments. Pharmaceut Med. 2025 https://doi.org/10.1007/s40290-025-00583-w
- Hariu A, Saino Y, Kuribayashi R. Consideration of the biosimilar drug lag and loss among Japan, the USA, and the EU. Naunyn Schmiedebergs Arch. Pharmacol. 2025. http://doi.org/10.1007/s00210-025-04494-0
- Kuribayashi R, Hariu A, Saino Y, Shinohara K. Efforts of the Pharmaceuticals and Medical Devices Agency of Japanese regulatory agency in supporting biosimilar development and disseminate information. Naunyn Schmiedebergs Arch Pharmacol. 2025; 398(7): 9357-65. https://doi.org/10.1007/s00210-025-03874-w
- Kuribayashi R, Goto K, Ogawa T. Trend Analysis of Regulatory Approvals for Generics and Biosimilars in Japan: 15 Years History of PMDA During Fiscal Years 2009–2023. AAPS J. 2024; 26(6): 113. https://doi.org/10.1208/s12248-024-00989-5
- Kuribayashi R, Goto K, Hariu A, Kishioka Y. Revisions to the requirement of the Japanese clinical study data for biosimilar developments in Japan. Expert Opin Biol Ther. 2024; 24(7):637-645. https://doi.org/10.1080/14712598.2024.2377300