The World Health Organization (WHO) has approved a biosimilar medicine of Trastuzumab, an affordable breast cancer drug.

The approval, known as a prequalification, is a first of its kind for Trastuzumab, the most potent but expensive drug in breast cancer treatment.

A biosimilar medicine is any drug made by another company but maintains the same quality and efficacy as the original product.



Prequalification is therefore used by WHO to confirm the quality, safety, and efficacy of biosimilar products that address global public health priorities.

The approval means that health agencies worldwide can purchase drugs, making it accessible and affordable to millions of people.

Trastuzumab is a monoclonal antibody-based drug originally produced by Genentech Inc. USA, sold under the trade name Herceptin, and costs $20,000.

Other biosimilars in the market do not have similar quality except the newly prequalified Trastuzumab, made by Samsung Bioepis of Netherlands. It’s also 65% cheaper and is comparable to the originator product in terms of efficacy, safety, and quality, according to the WHO.


Tedros Ghebreyesus, WHO director-general, said the successful production and testing by another drug company is “good news” and would make breast cancer treatment more affordable.

“WHO prequalification of biosimilar trastuzumab is good news for women everywhere,” he said.

“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.”

WHO estimated that the number of people suffering from breast cancers will reach 3.1 million by 2040, and much will come from low- and middle-income countries.


Therefore, the approval of a biosimilar for breast cancer is timely in making treatment affordable and preventing more deaths, according to Mariângela Simão, WHO assistant director-general for medicines and health products.

“We need to act now and try to avoid more preventable deaths. The availability of biosimilars has decreased prices, making even innovative treatments more affordable and hopefully available to more people,” said Simão.

According to a WHO Africa report, breast cancer is now ranked the leading site of disease (22.7%) and cause of death (18.6%) in Nigerian women.

A recent study of three countries in sub-Saharan Africa also found that treatment costs is a major contributor to not receiving treatment.


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