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Rituximab and Trastuzumab

Rituximab and Trastuzumab

In recent years, a great number of biotherapeutic products (BTPs) have demonstrated success in treating many life-threatening chronic diseases. In May 2014, the World Health Assembly (WHA) adopted Resolution WHA67.21 (2) on “Access to biotherapeutic products, including similar biotherapeutic products, and ensuring their quality, safety and efficacy”.

Considering the value that BTPs can provide and the fact that some BTPs have already been listed in the WHO Model List of Essential Medicines, WHO’s RPQ is exploring options to facilitate access to BTPs, including similar biotherapeutic products (SBPs), at affordable prices.

Given that BTPs, including their corresponding SBPs, are highly complex and that the regulatory assessment of those products according to internationally acceptable guidelines and standards can be challenging in some countries, WHO’s Prequalification Unit has developed a WHO pilot procedure for prequalification of two biotherapeutic products: rituximab or trastuzumab and is inviting manufacturers to submit an Expression of Interest (EOI) for product evaluation to the WHO Prequalification Unit – Biotherapeutic Products (BTPs).

This invitation to EOI is limited to:

  • Rituximab or Trastuzumab SBPs that have been registered by non-SRAs and will be assessed via a Full Assessment pathway. A similarity exercise (i.e., a head-to-head comparison of the SBP against a reference biotherapeutic product that, in turn, has been registered/licensed by an SRA on the basis of a full dossier with comprehensive data on non-clinical and clinical studies) will be required.
  • Rituximab or Trastuzumab BTPs, or their corresponding SBPs, that have been approved by stringent regulatory authorities (SRA) and marketed in the country of registration; and which will be assessed via an Abridged Assessment pathway.

As stated in the WHO Model List of Essential Medicines, rituximab is used principally to treat (a) diffuse large B-cell lymphoma, (b) chronic lymphocytic leukaemia or (c) follicular lymphoma, whereas trastuzumab is used to treat (y) early stage HER22 positive breast cancer or (z) metastatic HER2 positive breast cancer. These two BTPs, and their corresponding SBPs, have been selected for this WHO pilot procedure because: (i) they are some of the first monoclonal antibody therapies listed in the WHO Model List of Essential Medicines; (ii) there is established WHO technical guidance for evaluation of biotherapeutic protein products prepared by recombinant DNA technology, of SBPs and of monoclonal antibodies as SBPs ; and (iii) some SRAs now have extensive experience in evaluating these BTPs and their corresponding SBPs.

World Health Resolution WHA67.21: Access to biotherapeutic products including similar biotherapeutic products1 and ensuring their quality, safety and efficacy

Report on the Expert Consultation on Improving Access to and Use of Similar Biotherapeutic Products, 2‒3 May 2017

The WHO interim definition of a SRA is as follows:

  • a member of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), being the European Commission, the US Food and Drug Administration and the Ministry of Health, Labour and Welfare of Japan also represented by the Pharmaceuticals and Medical Devices Agency; or
  • an ICH observer, being the European Free Trade Association, as represented by Swissmedic, and Health Canada (as before 23 October 2015); or
  • a regulatory authority associated with an ICH member through a legally-binding, mutual recognition agreement, including Australia, Iceland, Liechtenstein and Norway (as before 23 October 2015).

For the purpose of WHO pilot procedure, this interim definition taken from the "WHO Technical Report Series TRS 1003, Fifty-first Report of the WHO Expert Committee on Specifications for Pharmaceutical Preparations" is used.

Note: This interim definition is currently being revised.

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