London, Dec. 19, 2019 (AltAfrica)-The World health organisation, W.H.O has prequalified the biosimilar version of the medicine trastuzumab, which has shown high efficacy in curing early stage breast cancer and, in some cases, more advanced forms of the disease.

WHO prequalifies first biosimilar medicine – trastuzumab – in a move that could make this expensive, life-saving breast cancer treatment more affordable and available to women globally https://t.co/wn1iYq5m22#WHOPrequalification pic.twitter.com/gHhPS85zxB

— World Health Organization (WHO) (@WHO) December 18, 2019

Prequalification means that WHO has assessed the medicine and it meets international standards, thus making it eligible for procurement by national health authorities.

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Trastuzumab normally costs around $20,000 per course, putting it out of reach for many women and healthcare systems. The biosimilar version, derived from biological sources, is around 65 per cent cheaper.

“WHO prequalification of biosimilar trastuzumab is good news for women everywhere,” said Tedros Adhanom Ghebreyesus, the 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.”

Although other biosimilar versions of trastuzumab are available, this marked the first time one has been prequalified by WHO.

Some 2.1 million women contracted the disease in 2018, with 630,000 dying because of late diagnosis and lack of access to affordable treatment.

WHO projects that rates will reach 3.1 million by 2040, with low- and middle-income countries recording the greatest increase.

The EC’s approval of Herzuma was based on results obtained from a Phase III clinical trial, which compared the safety and efficacy of the drug with trastuzumab in HER2-positive patients as a neoadjuvant and adjuvant treatment for one year.

The double-blind, randomised clinical study enrolled 549 patients with HER2-positive early breast cancer.

The primary endpoint of the study was pathological complete response (pCR) rate at surgery. The secondary endpoints were overall response rate, pharmacokinetics, pharmacodynamics and safety.

Results of the study demonstrated that the pCR rate at surgery in patients treated with Herzuma was 46.8% compared to 50.4% in patients treated with trastuzumab. The study also showed that all secondary efficacy endpoints were similar between Herzuma and reference trastuzumab.

It was also reported that the number of patients that underwent breast conservation surgery was similar for Herzuma and trastuzumab.