Essential medicines and health products

Global public consultation on WHO prequalification of similar biotherapeutic products

In October 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.

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 finalizing three documents that will be used for assessment of biosimilar products.

Three documents are as follows:

  • WHO Pilot procedure for prequalification of similar biotherapeutic products
  • WHO Guidelines on submission of documentation for the pilot procedure for prequalification of similar biotherapeutic products approved by stringent regulatory authorities
  • 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

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

The first Expression of Interest will be published in October 2017.

For any questions, contact us at:
prequalbiosimilar@who.int