WHO to Launch Pilot Project for Prequalifying Biosimilars to Treat Cancer

In an effort to increase access to biotherapeutic medications, the World Health Organization (WHO) will launch a pilot project for prequalifying biosimilar agents.

This September, manufacturers can submit applications for prequalification of biosimilars of rituximab and trastuzumab, BioSpectrum reported.

The decision follows a 2-day meeting in Geneva between the WHO, pharmaceutical industry groups, payers, policymakers, national regulators, and patient and civil society groups.

It is the latest step towards making expensive cancer drugs more widely available in low- and middle-income countries, BioSpectrum reported. The WHO also plans to explore options for prequalifying insulin.

“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 Dr Marie-Paule Kieny, WHO assistant director general for Health Systems and Innovation, as reported by BioSpectrum.

If the biosimilars submitted for prequalification are comparable in safety, efficacy, and quality to the biologics, the medications will be listed by WHO and become eligible for procurement by United Nations agencies.

Many low- and middle-income countries rely on WHO prequalification before purchasing medications, according to BioSpectrum.

“Biosimilars could be game-changers for access to medicines for certain complex conditions,” said Dr Suzanne Hill, WHO’ director of Essential Medicines and Health Products, as reported by BioSpectrum. “But they need to be regulated appropriately to ensure therapeutic value and patients safety.”

The WHO noted that they will also advocate for fairer prices for all biotherapeutics, including lending support to countries to develop price-setting strategies for sustainable markets that deliver treatments to patients, savings to payers, and incentives to continue manufacturing these medications.