The World Health Organization (WHO) has prequalified a biosimilar medicine that could make this breast cancer 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 per cent of breast cancers. It has shown high efficacy in curing early stage breast cancer – and in some cases, more advanced forms of the disease.
Biotherapeutic medicines are produced from biological sources such as cells rather than synthesised chemicals. Like generic medicines, biosimilars can be much less expensive versions of innovator biotherapeutics, while being equally effective. They are usually manufactured by other companies once the patent on the original product has expired.
WHO prequalification gives countries the assurance that they are purchasing quality health products. While a few biosimilars of trastuzumab emerged in the market over the last five years, but none had been prequalified by WHO before.
The global average cost of trastuzumab from originator companies is SGD 27, 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 per cent cheaper than the originator.
With the WHO listing, and more products expected in the prequalification pipeline, prices are set to decrease even further.
“WHO prequalification of biosimilar trastuzumab is good news for women everywhere,” said Dr Tedros Adhanom Ghebreyesus, WHO Director-General. “Women in many cultures suffer from gender disparity when it comes to accessing health services. In poor countries, there is the added burden of a lack of access to treatment for many, and the high cost of medicines,” he added.
Breast cancer is the most common form of cancer in women. In 2018, 2.1 million women contracted breast cancer, with 630 000 of them dying from the disease. Many of the deaths were due to late diagnosis and lack of access to affordable treatment.
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.