WHO launches consultation on prequalification of biosimilars Posted 15/09/2017

The World Health Organization (WHO) announced in September 2017 that it would be launching its pilot project for prequalifying biosimilars in October 2017. The step is intended to make ‘some of the most expensive treatments for cancer more widely available in low- and middle-income countries’.

The WHO prequalification of medicines is a service provided by the organization to assess the quality, safety and efficacy of medicinal products. It was started in 2002 in partnership with UNAIDS (Joint United Nations Programme on HIV/AIDS), UNICEF (United Nations Children's Fund) and the UN Population Fund, with support from the World Bank [1]. At the end of 2012, the WHO List of Prequalified Medicinal Products contained 316 medicines for priority diseases.

In order to provide clear guidance to manufacturers wishing to apply for the pilot project, WHO will be using two assessment pathways. These will include one for applicants with products approved by a stringent regulatory authority and another for applications with products that were approved by other National Regulatory Authorities.

WHO intends to use the following three documents to assess biosimilars:

  • 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

These documents are currently being finalized. However, despite this, the organization will publish its first Expression of Interest covering both rituximab and trastuzumab in October 2017. Questions regarding WHO prequalification for biosimilars can be submitted to prequalbiosimilar@who.int.

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use recommended approval of Sandoz’s rituximab biosimilars (Rixathon and Riximyo) in April 2017 [2]. EMA has not yet approved a trastuzumab biosimilar. However, Amgen, Biocon/Mylan, Celltrion and Samsung Bioepis/Merck have all submitted applications for their trastuzumab biosimilars to EMA. Amgen, Biocon/Mylan and Celltrion have also submitted applications to the US Food and Drug Administration [3].

Related article
WHO proposes provisional implementation of Biological Qualifier

References
1. GaBI Online - Generics and Biosimilars Initiative. WHO prequalification programme for medicines [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Sep 15]. Available from: www.gabionline.net/Policies-Legislation/WHO-prequalification-programme-for-medicines
2. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Sep 15]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Europe
3. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of trastuzumab [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Sep 15]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-of-trastuzumab

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Source: WHO

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