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
PDF[53.6KB]
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
January 25, 2024
PSB/PED Administrative Notice
February 4, 2020
PSEHD/PED Notification No. 0204-1
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
- Kuribayashi R. Regulatory Experience and Considerations to Date from PMDA. IPRP Biosimilar Workshop. September 2023[155KB]
- Hayamizu K. Biosimilar Regulation and Guidelines in Japan. Global Bio Conference 2023. August 2023[1.43MB]
- Kishioka Y. Regulatory Updates on Biosimilars in Japan. 19th Biosimilar Medicines Conference. May 2023[867KB]
Publications
- Kuribayashi R, Hariu A, Nakano A, Kishioka Y. Survey of Data Package and Sample Size of Comparative Clinical Studies for Biosimilar Developments from PMDA Assessments. Pharmaceut Med. 2024; 38: 225-239. https://doi.org/10.1007/s40290-024-00525-y
- 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. BioDrugs. 2023; 37(4): 443-451. https://doi.org/10.1007/s40259-023-00605-6