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First biosimilar drug prequalified by WHO to increase access to breast cancer treatment

On 18th December 2019, the World Health Organization prequalified its first biosimilar medicine – trastuzumad, in attempts to make the expensive treatment for breast cancer readily available to all women globally.

Like the name suggests, breast cancer forms in the cells of the breasts. It can occur both in men and women, however, is far more common in the latter. Signs of the cancer may include a lump in the breast, a change is breast’s shape, dimpling of the skin, red scaly patch of skin or fluid coming out of the nipple. Symptoms me also include bone pain, yellow skin, swollen lymph nodes and shortness of breath is the cancer has spread.

Due to the expensive treatment of the cancer, it’s inaccessible my most women across the globe. 2.1 million women had breast cancer in 2018, out of which 630,000 passed away due to the unaffordability of the treatment drugs.

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A biosimilar medicine is a highly similar version of a reference biological medicine. It can be used as a less costly substitute for the original medicine and has been proven to be equally effective. The processes of production are naturally variable and hence, no two batches are exactly the same.

The medicine supplied by Samsung Bioepis NL B.V. (Netherlands) was evaluated and assessed by WHO and was found comparable in terms of efficacy, safety and quality to the originator product.

World health organization prequalified trastuzumad in hopes of improving affordability and accessibility and reducing the overall mortality rate due to breast cancer.

Trastuzumad is a monoclonal antibody which was included in the WHO Essential Medicines List in 2015 as a mandatory treatment for about 20% of breast cancers. The drug has shown high efficacy in curing early stage cancer and in some cases is effective for advanced disease as well.

The average cost of Trastuzumad from the parent companies in around $20,000 which makes it unaffordable for a large majority of women. The biosimilar version is 65% cheaper.

According to Dr Tedros Adhanom Ghebreyesus, WHO Director-General, “WHO prequalification of biosimilar trastuzumab is good news for women everywhere. 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.”

A few biosimilar versions of Trastuzumad have come to the market in the last 5 years, however, none had been prequalified by WHO until now. Prequalification basically gives countries assurance that they are purchasing high quality products.

According to a recent study of breast cancer in sub-Saharan Africa, from 1325 women surveyed over 3 countries, treatment had not been started within one year of diagnosis in 227 women and for 185 with stage I-III cancer.

Dr Mariângela Simão, WHO Assistant Director General for Medicines and Health Products talked about the availability of biosimilars saying, “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.”

About World Health Organization (WHO)

WHO is a specialized agency of the United States primarily concerned with international public health. The organization played a vital role in the eradication of small pox and is now concerned with “communicable diseases, in particular HIV/AIDS, Ebola, malaria and tuberculosis; the mitigation of the effects of non-communicable diseases such as sexual and reproductive health, development, and aging; nutrition, food security and healthy eating; occupational health; substance abuse; and driving the development of reporting, publications, and networking.”


Mariyam Tanveer

Recently graduated from LUMS, I now work as Researcher and a Freelance Writer on Ask Health News

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