WHO aims to increase uptake of biosimilars in poorer countries

The WHO has announced that it will launch a project to prequalify biosimilar medicines for the treatment of certain cancers. The aim, as announced by WHO, is to make some of the more expensive treatments for cancer to be more widely available in lower and middle-income countries.

In particular, the WHO has invited manufacturers to submit applications for prequalification of biosimilar versions of two drugs on the Essential Medicines List: rituximab (Rituxan) and trastuzumab (Herceptin, by Roche). Rituximab is used to treat non-Hodgkin’s lymphoma and chronic lymphocytic leukaemia while trastuzumab is used to treat breast cancer.

"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.

Encouraging manufacturers to produce lower-cost biosimilars of the drugs is part of an overall attempt to improve access to drugs for those in poorer countries. If the WHO finds a biosimilar to be similar, in terms of its quality, safety and efficacy, to the originator product then it would be able to be sourced by United Nations agencies.

With an increase in competition, there is hope that producers of the original medicine would be forced to drop its price compete with the biosimilar competition. The WHO is also looking at prequalifying biosimilars of insulin, another medicine that is prohibitively expensive in various countries around the world.

"Biosimilars could be game-changers for access to medicines for certain complex conditions," said Dr Suzanne Hill, WHO’s Director of Essential Medicines and Health Products. "But they need to be regulated appropriately to ensure therapeutic value and patient safety."