Pmda - Pharmaceuticals and Medical Devices Agency

Reviews and Related Services


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

Under construction

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

February 4, 2020
PSEHD/PED Notification No. 0204-1

January 25, 2024
PSB/PED Administrative Notice

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.

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  • 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.