Japanese Biosimilars Guideline

August 29, 2011 8:17 PM

The Ministry for Health Labour and Welfare (MHLW) is the authority in Japan that is responsible for the scientific evaluation of medicines and assures the quality of medicines in the country.

The Pharmaceuticals and Medical Devices Agency (PMDA) is a Japanese regulatory agency which conducts scientific reviews of marketing authorisation application of pharmaceuticals and medical devices, monitoring of their post-marketing safety. PMDA is also responsible for providing relief compensation for sufferers from adverse drug reactions by pharmaceuticals that are on the Japanese market. PMDA’s Office of Biologicals provides recommendations concerning the clinical trials of new molecules, medical devices and controls 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 products that are equivalent and similar 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.

The Japanese biosimilar guideline is named “Guideline for the quality, safety and effectiveness of biosimilar products“. The guideline covers all biosimilar products and is published in Japanese which can be accessed from here.

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