WHO to launch pilot prequalification for biosimilar cancer treatments

The World Health Organization (WHO) on Thursday said it would launch a pilot project for prequalifying biosimilar medicines this year in a step towards making some of the most expensive treatments for cancer more widely available in low and middle-income countries.

Biotherapeutic medicines, which are produced from biological sources such as cells rather than synthesized chemicals, are important treatments for some cancers and other non-communicable diseases. Biosimilars could help to increase access to treatment in lower-resourced countries and provide a solution to escalating health costs in high-income countries.

"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, WHO assistant director general for Health Systems and Innovation.

In September, WHO will invite manufacturers to submit applications for prequalification of biosimilar versions of two products in the WHO essential medicines list: rituximab (used principally to treat non-Hodgkin's lymphoma and chronic lymphocytic leukemia), and trastuzumab (used to treat breast cancer).

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.

WHO highlighted that many low and middle-income countries also rely on WHO prequalification before buying medicines. An additional benefit of prequalification could be to increase competition and further reduce the price of medicines. Endit