Regulation of biosimilars in Japan

INICIO/Informes | Posted 23/09/2016 post-comment0 Post your comment

Biosimilar regulations, based on the European Union’s existing processes, were issued by Japan’s regulatory body for the approval of medicines, the Ministry for Health, Labour and Welfare (MHLW), in March 2009 [1]. The MHLW’s regulatory agency, the Pharmaceuticals and Medical Devices Agency (PMDA), provides consultations concerning the clinical trials of new drugs and medical devices and handles biotechnology medicines, including biosimilars.


Although there are many similarities between Japan and other highly regulated countries/regions in their approach to the regulation of biosimilars, differences still exist. Harmonization of such differences would be of great advantage to global biosimilars makers, reducing costs and levelling the playing field for manufacturers from different countries/regions.

In his presentation at the 14th Annual Biosimilars Group Conference, Dr Daisaku Sato, Director, Office of Cellular and Tissue-based Products at PMDA, discusses the regulation of biosimilars in Japan [2]. Topics covered include the type of reference product that will be accepted, toxicity studies, naming, interchangeability, extrapolation of indications and sharing of information with other agencies.

In the following series of three articles specific aspects of the regulation of biosimilars in Japan are presented and discussed.

Editor’s comment
Readers interested to learn more about regulations for biosimilars in Japan are invited to visit to view the following manuscript published in GaBI Journal:

Biosimilar development and regulation in Japan

GaBI Journal is now indexed in Embase, Scopus, Thomson Reuters’ ESCI, and more.

Readers interested in contributing a research or perspective paper to GaBI Journal – an independent, peer reviewed academic journal – please send us your submission here.

If you would like to receive a PDF copy* of the Daisaku presentation [2], please send us an email.

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Related articles
Extrapolation of indications for biosimilars in Japan

Naming and interchangeability for biosimilars in Japan

Reference products and toxicity studies for biosimilars in Japan

1. GaBI Online - Generics and Biosimilars Initiative. Japanese guidelines for biosimilars []. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Sep 23]. Available from:
2. Daisaku S. Surfing the wave in Japan for Regulatory Convergence of Biosimilar. 14th Annual Biosimilar Medicines Group Conference; 28–29 April 2016; London.

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