What is biosimilar medicine?
Biotherapeutic medicines are produced from biological sources such as cells rather than synthesized chemicals, are important treatments for some cancers and other non-communicable diseases. Like generic medicines, biosimilars can be much less expensive versions of innovator biotherapeutics while keeping the same effectiveness. They are usually manufactured by other companies once the patent on the original product has expired.
What is WHO Prequalification?
Every year, billions of dollars’ worth of medicines and other health products are purchased by international procurement agencies for distribution in low-income countries. Prequalification is a service provided by WHO to assess the quality, safety and efficacy of those 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.
Breast cancer is the most common form of cancer in women. 2.1 million women contracted breast cancer in 2018. 630 000 of them died from the disease, many because of late diagnosis and lack of access to affordable treatment.
The World Health Organization (WHO) prequalified its first biosimilar medicine – trastuzumab – in a move that could make this expensive, life-saving treatment more affordable and available to women globally.
Trastuzumab – a monoclonal antibody – was included in the WHO Essential Medicines List in 2015 as an essential treatment for about 20% of breast cancers. Trastuzumab in combination with chemotherapy has long been established as a standard treatment for HER2-positive patients in early stage breast cancer (BC). It has shown high efficacy in curing early stage breast cancer and in some cases more advanced forms of the disease.
The biosimilar version of trastuzumab is generally 65% cheaper than the originator. With this WHO listing, and more products expected in the prequalification pipeline, prices should decrease even further.
The medicine, supplied by Samsung Bioepis NL B.V. (Netherlands), was assessed by WHO and found comparable to the originator product in terms of efficacy, safety and quality. That means it is eligible for procurement by United Nations agencies and for national tenders.
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