WHO Prequalifies Samsung Bioepis' Biosimilar Trastuzumab

The World Health Organization (WHO) this week prequalified its first biosimilar. The product, Samsung Bioepis’ biosimilar trastuzumab, Ontruzant, referencing Herceptin, could now become available to more patients with HER2-positive cancer in low- and middle-income countries.

Prequalification ensures that medicines supplied by international procurement agencies meet acceptable standards of quality, safety, and efficacy, and it gives the procurement agencies working to distribute drugs in resource-limited areas the choice of a range of medicines for bulk purchase. Many low-income countries use WHO’s list of prequalified products to guide their selection of medicines, and prequalification may also contribute to an increase in competition that reduces costs for these medicines.

“WHO prequalification of biosimilar trastuzumab is good news for women everywhere,” said Tedros Adhanom Ghebreyesus, PhD, WHO’s director-general, in a statement. “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 WHO noted that the biosimilar is being made available at price 65% lower than the global average cost of the originator drug, and with more products expected to enter the prequalification pipeline, competition could see prices drop even further. That could be key to ensuring access as the number of diagnoses of breast cancer rises; the WHO said that, by 2014, the number of patients diagnosed with breast cancer could reach 3.1 million, with most of those patients residing in low- and middle-income nations.

This week’s news is a major development after the WHO announced the pilot prequalification project in 2017 and invited drug makers to submit applications for their biosimilar versions of trastuzumab and rituximab (referencing the brand-name Rituxan).

The organization is also currently working on a pilot procedure for the prequalification of human insulin as means to facilitate access to safe, effective, and quality-assured products for use in low-resource areas.