WHO Mulls over prequalifying Copies of Cancer drugs for Affordable treatments

WHO Mulls over prequalifying Copies of Cancer drugs for Affordable treatments

By Samwel Doe Ouma

World health organization (WHO) plans to launch a pilot project for prequalifying biosimilar medicines in an effort of making cancer treatments affordable and widely available in low and middle income countries.

According to a press statement, WHO will invite manufacturers to submit applications for prequalification of biosimilar versions of two products in the WHO essential medicines list in September.

The two biosimilar medicines- rituximab -used principally to treat non-Hodgkin's lymphoma and chronic lymphocytic leukemia and -trastuzumab -used to treat breast cancer will be prequalified. The decision which 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 declared. 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 can be much less expensive versions of innovator biotherapeutics. They are usually manufactured by other companies once the patent on the original product has expired. Like generic medicines, biosimilars could help to increase access to treatment in lower-resourced countries and provide a solution to escalating health costs in high-income countries.

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.