WHO’s prequalification programme was first established in 2001 and offers guidance on the acceptability of medical products (including drugs, vaccines, diagnostics and medical devices) ahead of their procurement to UN (United Nation) agencies and WHO Member States. As of 2012, there were over 300 medicines on the WHO List of Prequalified Medicinal Products.

All prequalified products must meet WHO technical guidance on quality, safety and efficacy, and be compliant with WHO standards on good practices (including Good Manufacturing Practice, Good Laboratory Practice and Good Clinical Practice).

WHO announced the pilot for prequalifying biosimilars in May 2017 [1]. The Organization invited manufacturers to submit applications for prequalification of biosimilars of rituximab, used to treat non-Hodgkin’s lymphoma and leukaemia, and trastuzumab, which is sold under the brand name Herceptin and is a popular treatment option for breast cancer.

At the 17th Biosimilar Medicines Conference, held on 29 March 2019 in The Netherlands, Director of Regulation of Medicines and other Health Technologies (RHT) Emer Cooke confirmed that the pilot for the prequalification of these drugs launched in June 2018. Rituximab and trastuzumab are among the first monoclonal antibody therapies to be listed in the WHO Model List of Essential Medicines.

Cooke outlined two assessment pathways for the biosimilars. The full assessment pathway applies to biosimilars that have been registered by non-stringent regulatory authorities (SRAs), using an SRA-approved reference drug as comparator and for marketing in the country of registration. Under the abridged assessment pathway, originator products or biosimilars for rituximab and trastuzumab have been approved by an SRA and marketed in the country of the SRA.

As of February 2019, 18 dossiers have been received by WHO, divided equally between the two assessment pathways. Assessors and inspectors have been nominated from 10 countries spanning Africa and Asia, and Europe.

The outcome of all the abridged assessments has been communicated by WHO, while pre-submission meetings have been held for all applications made under the full assessment pathway.

The presentation also highlighted a number of issues observed during the application process so far. In the full assessment pathway, for example, Emer Cooke noted that data contained in the dossiers was in many cases insufficient to demonstrate similarity between the reference product and the biosimilar (in terms of quality, safety and efficacy).

For the abridged pathway, Cooke said applicants have not adapted their dossiers to patient treatment and current clinical practice in low- and middle-income countries (for example, in terms of pharmacovigilance and handling complaints).

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Reference
1. GaBI Online - Generics and Biosimilars Initiative. WHO to launch prequalification programme for biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Apr 26]. Available from: www.gabionline.net/Biosimilars/General/WHO-to-launch-prequalification-programme-for-biosimilars

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