WHO to Begin Pilot Prequalification of Biosimilars for Cancer Treatment


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This year, the World Health Organization (WHO) will launch a pilot project for prequalifying biosimilar medicines, a step toward making some of the most expensive treatments for cancer more widely available in low- and middle-income countries. The decision comes after a 2-day meeting in Geneva among WHO, national regulators, pharmaceutical industry groups, patient and civil society groups, payers, and policymakers to discuss ways to increase access to biotherapeutic medicines.

In September, WHO will invite manufacturers to submit applications for prequalification of biosimilar versions of two products in the WHO Essential Medicines List: rituximab (Rituxan), and trastuzumab (Herceptin). WHO also plans to explore options for prequalifying insulin.

Marie-Paule Kieny, PhD

Marie-Paule Kieny, PhD

“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,” said Marie-Paule Kieny, PhD, WHO Assistant Director General for Health Systems and Innovation.

Potential ‘Game-Changers’

If WHO finds that the biosimilars submitted for prequalification are comparable to originator products in terms of quality, safety, and efficacy, the medicines will be listed by WHO and become eligible for procurement by United Nations agencies. Many low- and middle--income countries also rely on WHO prequalification before buying medicines. 

An additional benefit of WHO prequalification could be to increase competition and further reduce the price of medicines. WHO will advocate for fairer prices for all biotherapeutics to ensure that these treatments can truly benefit public health.

“Biosimilars could be game-changers for access to medicines for certain complex conditions,” said Suzanne Hill, BMed (Hons), Grad Dip Epi, PhD, -FAFPHM, WHO’s Director of Essential Medicines and Health Products. “But they need to be regulated appropriately to ensure therapeutic value and patient safety.”

Increased use of biosimilars will also require patients and their physicians to understand and trust that the benefits of this type of medicine substantially outweigh any risks. ■


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