WHO to make biosimilars more available in poor countries
The World Health Organization (WHO) will launch a pilot project for biosimilars to make costly cancer treatments more widely available in low and middle income countries.
As announced in a press release yesterday, WHO said that it will invite manufacturers to submit applications for “prequalification” of biosimilar versions of rituximab, a treatment for chronic lymphocytic leukemia, and breast cancer treatment trastuzumab in September this year.
Both the drugs are on the WHO Essential Medicines List, which contains the medications considered to be most effective and safe to meet the most important needs in a health system.
Dr Marie-Paule Kieny, WHO assistant director general for health systems and innovation, said: “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.”
The decision comes after a two-day meeting in Geneva between WHO, national regulators, pharmaceutical industry groups, patient and civil society groups, payers and policy makers to discuss ways to increase access to biotherapeutic medicines.
The organisation also plans to explore options for prequalifying insulin.
According to the press release, WHO will review its 2009 guidelines on the evaluation of biosimilar products to “ensure that WHO’s guidance to national regulatory authorities reflects recent evidence and experience”.
Suzanne Hill, director of essential medicines and health products of WHO, said: “Biosimilars could be game-changers for access to medicines for certain complex conditions.”
She added: “But they need to be regulated appropriately to ensure therapeutic value and patient safety.”
WHO said that it will also advocate for fairer prices for all biotherapeutics by supporting countries to develop price-setting strategies to ensure that the treatments can benefit public health.
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