Today 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.

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.

“WHO prequalification of biosimilar trastuzumab is good news for women everywhere,” says 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. Effective, affordable breast cancer treatment should be a right for all women, not the privilege of a few.”

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.

A recent study of breast cancer in sub-Saharan Africa found that of 1325 women surveyed in three countries, cancer treatment had not been initiated within one year of diagnosis for 227 (17%) women and for 185 (14%) women with stage I-III disease. Self-reported treatment barriers confirmed treatment costs as a major contributor to not receiving 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.

“We need to act now and try to avoid more preventable deaths,” says Dr Mariângela Simão, WHO Assistant Director General for Medicines and Health Products. “The availability of biosimilars has decreased prices, making even innovative treatments more affordable and hopefully available to more people.”

Note to editors

Biotherapeutics

Biotherapeutics are pharmaceutical products derived from biological and living sources. They include therapeutic vaccines, blood, blood components, cells, gene therapies, tissues and other materials.

Several biologic medicines are ‘specialty drugs’, highly priced and effective in treating medical conditions for which no other treatments are available. Gene- and cell-based therapies are among these pharmaceuticals.

Some biotherapeutics are effective treatments for certain forms of cancer, chronic diseases such as diabetes, Crohn’s disease and other autoimmune conditions, including lupus, and various forms of rheumatoid arthritis.

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.

In July 2018, WHO launched a pilot project expanding the scope of prequalification to two biotherapeutic medicines, as a step towards making some of the most expensive treatments for cancer more widely available in low- and middle-income countries. This is the first biotherapeutic to be prequalified as part of the pilot.

