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Global public consultation on WHO prequalification of similar biotherapeutic products

In September this year WHO will launch a pilot project for prequalifying biosimilar medicines, a step towards making some of the most expensive treatments for cancer more widely available in low- and middle-income countries.

WHO will invite manufacturers to submit applications for prequalification of biosimilar versions of two products in the WHO Essential Medicines List: rituximab (used principally to treat non-Hodgkin's lymphoma and chronic lymphocytic leukemia), and trastuzumab (used to treat breast cancer).

To provide clear guidance to manufacturers wishing to apply for the pilot project, WHO will be using two assessment pathways, for applicants with products approved by a stringent regulatory authority and for applications with products that were approved by other NRAs.

WHO is currently seeking comments on three documents that will be used for assessment of biosimilar products.

Three documents are as follows:

  1. WHO Pilot procedure for prequalification of similar biotherapeutic products
  2. WHO Guidelines on submission of documentation for the pilot procedure for prequalification of similar biotherapeutic products approved by stringent regulatory authorities
  3. WHO Guidelines on submission of documentation for the pilot procedure for prequalification of similar biotherapeutic products. Preparation of product dossiers in common technical document format

Deadline for comments is 23.59 on Wednesday 16 August 2017.

Please use the template provided below for submission of comments:

Template for submission of comments doc

Comments should be submitted to: prequalbiosimilar@who.int

For a definition of a stringent regulatory authority, please see here:  http://www.who.int/medicines/areas/quality_safety/quality_assurance/expert_committee/trs_1003/en/

The first Expression of Interest, covering both rituximab and trastuzumab, will be published in early September 2017.