update - WHO outlines biosimilarity requirements and inspection plan

WHO plans biosimilar prequalification scheme to increase access to cancer meds

By Gareth Macdonald

- Last updated on GMT


Related tags World health organisation World health organization Medicine

The WHO has announced plans to extend its prequalification scheme to include cancer biosimilars and says it will pressure industry for fairer prices for all biologics.

From September, the World Health Organisation (WHO) will accept applications from drug firms seeking assessment of biosimilar versions of the Roche drugs Rituxan (rituximab) and Herceptin (trastuzumab).

Products deemed equivalent to the innovator versions in terms of quality, safety and efficacy will be “prequalified,” which means United Nations (UN) agencies can procure them for aid programmes.

In addition, many countries use “prequalification” as an indicator of quality when sourcing medicines for national healthcare programmes according to the WHO.

Marie-Paule Kieny, WHO Assistant Director General for Health Systems and Innovation, said the aim is to make the drugs more widely available.

Innovator biotherapeutic products are often too expensive for many countries, so biosimilars are a good opportunity to expand access and support countries to regulate and use these medicines​” she said.

The WHO is also looking at extending the scheme to include versions of insulin.


The World Health Organisation (WHO) began prequalifying drug suppliers in 2001 in an effort to ensure HIV/AIDS, malaria and TB medicines sourced by national procurement agencies were of appropriate quality.

The prequalification scheme has since been expanded to all drugs on the WHO’s essential medicines list​ and active pharmaceutical ingredients (API).

Price pressure

The WHO announced the prequalification plan alongside a commitment to “advocate for fairer prices for all biotherapeutics​.”

The organisation said it plans to help low and middle income countries “develop price-setting strategies that foster sustainable markets to deliver treatments to patients, savings to payers and incentives to producers to keep manufacturing the medicines needed​.”

Suzanne Hill, Director of Essential Medicines and Health Products, told us the WHO "will support countries to develop appropriate pricing policies, and undertake price negotiation with industry to ensure that prices are fair and affordable​."


Emer Cooke, Head of Regulation of Medicines and Other Health Technologies, told us how the WHO will go abut determining a biosimilars' similarity to the originator drug.

She said the "WHO will ask companies to follow the relevant WHO scientific guidelines which aim to assure quality, safety and efficacy​" adding the organisation "will also engage experts with experience in the assessment of bisosimilars to advise on comparability​."

Site inspections will also be a reactive process Cooke continued, explaining "additional inspection and assessment resources will depend on the number and nature of applicants​" adding that the WHO will assess the need for additional resources once the pilot project has been completed."

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