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Pharmaceuticals and Medical Devices Agency (Japan) pmda.go.jp

[SHINSA]Information on biosimilars is updated

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Announcement

Safety Classified by Officially

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.

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.

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

  • Review of Biosimilars - PMDA-ATC Learning Video - YouTube

    • You will be transferred to an external website (YouTube : Pmda Channel) by clicking the image.

  • 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; 39: 477-91.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

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    October 14, 2026 03:33
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