World health organization (WHO) plans to launch a pilot project for prequalifying biosimilar medicines in an effort to make cancer treatments affordable and available in low and middle-income countries.
According to a press statement, WHO intends to invite manufacturers to submit applications in September for prequalification of two versions of biosimilar products in the WHO essential medicines list.
The two medicines rituximab and trastuzumab. The former is used principally to treat non-Hodgkin’s lymphoma and chronic lymphocytic leukemia while the latter treats breast cancer. The decision comes after a two-day meeting in Geneva between WHO, national regulators, pharmaceutical industry groups, patient and civil society groups, payers and policymakers to discuss ways to increase access to biotherapeutic medicines. 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.
Biotherapeutic medicines are produced from biological sources such as cells rather than synthesised chemical. They are important treatments for some cancers and other non-communicable diseases. Like generic medicines, biosimilars are inexpensive versions of innovator biotherapeutics.
They are manufactured after expiry of the patent on the original product. Like generic medicines, biosimilars could help to provide a solution to escalating global health costs.
Increased use of biosimilars will require patients and their physicians to understand and trust that the benefits of this type of medicine substantially outweigh any risks.
“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.”
Prequalification is a service provided by WHO to assess the quality, safety and efficacy of products that address global public health priorities. If the products meet international standards, they are listed on the WHO web site as eligible for procurement, giving purchasing agencies a range of quality-assured diagnostics, medicines and vaccines from which to choose. Many low-income countries also use WHO’s lists of prequalified products to guide their selection of medicines, vaccines and technologies for national procurement.
