WHO to begin pilot prequalification of biosimilars for cancer treatment
The World Health Organization (WHO) announced plans to launch a pilot program for prequalifying biosimilar medications.
The World Health Organization (WHO) announced plans to launch a pilot program for prequalifying biosimilar medications. Beginning this September, WHO will invite manufacturers to submit applications for prequalification of biosimilar versions of two products in the WHO Essential Medicines List: rituximab (used mainly to treat non-Hodgkin's lymphoma and chronic lymphocytic leukemia), and trastuzumab (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 Marie-Paule Kieny, MD, WHO Assistant Director General for Health Systems and Innovation. The decision follows a 2-day meeting in Geneva between WHO, national regulators, pharmaceutical industry groups, patients and civil society groups, payers, and policymakers to talk about ways to boost access to biotherapeutic medications. WHO said it also plans to explore options for prequalifying insulin.