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.
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.
Trastuzumab – a monoclonal antibody – was included in the WHO Essential Medicines List in 2015 as an essential treatment for about 20% of breast cancers. It has shown high efficacy in curing early stage breast cancer and in some cases more advanced forms of the disease.
The global average cost of trastuzumab from originator companies is $20 000, a price that puts it out of reach of many women and healthcare systems in most countries. 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.
Biotherapeutic medicines, which 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.
A few biosimilars of trastuzumab have come to market in the last five years, but none had been prequalified by WHO before today. WHO prequalification gives countries the assurance that they are purchasing quality health products.
WHO’s International Agency for Research on Cancer estimates that by 2040 the number of diagnosed breast cancers will reach 3.1 million, with the greatest increase in low- and middle-income countries.
