IPRF template for summary information for biosimilar reviews

Biosimilars/General | Posted 01/04/2016 post-comment0 Post your comment

The Biosimilars Working Group (BWG) of the International Pharmaceutical Regulators Forum (IPRF) has released a template for Public Assessment Summary Information for Biosimilar (PASIB).

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The purpose of the IPRF is to create an environment for pharmaceutical regulators to exchange information on issues of mutual concern and regulatory cooperation. The group is proposing the development of a template to assist National Regulatory Authorities (NRA) in making available a summary of the review of biosimilar applications in their country in a common language, e.g. English.

The IPRF points out that in countries that already publish assessment reports following the review of an application for marketing approval, this is often published in the local language. This the IPRF points out does not make the results easily accessible to the wider (global) community. Therefore, in order to increase transparency and to ease the transition between the local language and English, the group has proposed that the PASIB be used.

The PASIB includes key information and summarized details of the biosimilar review and is expected to be of more use to countries that currently do not publish their reviews or do so only in a local language that is not English.

The IPRF has published the proposed template as well as instructions on how to complete the form and four completed examples.

The template and accompanying instructions have been released for a 2-month consultation period. Comments can be submitted via the IPRF website (www.i-p-r-f.org) or via e-mail (Secretariat.IPRF@swissmedic.ch). The deadline for comments is 9 May 2016.

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