Japanese guidelines for biosimilars

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Last update: 21 October 2016

The Ministry for Health Labour and Welfare (MHLW) is the regulatory body in Japan responsible for the scientific evaluation of medicines developed by pharmaceutical companies for use in Japan and makes the decision on approval of drugs, including biologicals.


The Pharmaceuticals and Medical Devices Agency (PMDA) is a Japanese regulatory agency, working together with MHLW. PMDA conducts scientific reviews of marketing authorisation application of pharmaceuticals and medical devices, monitoring of their post-marketing safety; and is also responsible for providing relief compensation for sufferers from adverse drug reaction and infections by pharmaceuticals or biological products. PMDA's Office of Biologicals provides consultations concerning the clinical trials of new drugs and medical devices and handles biotechnology medicines including biosimilars.

In Japan, guidelines, based on the EU’s existing processes, were published by the MHLW in March 2009. These guidelines consider biosimilar drugs that are equivalent and homogenous to the reference biological product in terms of efficacy, quality and safety. The applications must be submitted with data from clinical trials, details of manufacturing methods, long-term stability data and information on overseas use.

In June 2009, Sandoz received approval for its recombinant human growth hormone somatropin, the first biosimilar in Japan.

Overarching guideline
This guideline covers all biosimilar products:

Guideline for the quality, safety and effectiveness of follow-on drugs (in Japanese)
Date: March 2009

In theory all kinds of biosimilars can be developed, however, the guideline deals with recombinant protein products in which the definition of desired product is clear, and the approach for characterization is relatively easy.

4. Other guidelines
Other guidelines relevant for biosimilars from PMDA include:

Marketing Approval Application for follow-on drugs
PFSB Notification 0304004
Date: 4 March 2009

Non proprietary Name and Drug Name of follow-on drugs
PFSB/ELD Notification No. 0214-1, Administrative Notice
Date: 14 February 2013

Questions & Answers regarding Guideline
PFSB/ELD Administrative Notice
Date: 15 December 2015

Related article
Biosimilars approved in Japan 

Hurdles to biosimilars in Asia

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Source: MHLW, PMDA, HIS, Stratycon, Visiongain

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