WHO approved first Biosimilar Medicine

Trastuzumab, also known as Herceptin, is the first targeted biosimilar medicine for breast cancer. In 1986, Alex Ullrich, while being an employee in Genentech, discovered a protein created by the genes of the HER2 gene. It is considered an oncogene which is the major cause of cancer. The monoclonal antibody i.e., Herceptin limits the HER2 receptors. These receptors are located on the HER2-positive tumour cell’s surface. The receptors block the tumour cells from getting the required growth signals and indicate to them the damage caused by the immune-system. It is the first biosimilar medicine for breast cancer approved by the World Health Organization as the innovator of Trastuzumab proposed it for the treatment of early breast cancer. 

What is breast cancer?

Breast cancer is a form of cancer that occurs in either one or both breasts. It occurs when the cells in the body start growing out of control. Breast cancer occurs for several reasons, such as drinking too much alcohol, being overweight in body or obese, being physically inactive, not breastfeeding, birth control, or genetic reasons.

An overview of Trastuzumab 

• A decade ago, the monoclonal antibody was measured only to estimate prognoses. In 1990, an anti-monoclonal antibody was developed by the innovator of Trastuzumab, blocking the tumour-stimulating impacts of the HER2 gene. The anti-monoclonal body was referred to as Trastuzumab or Herceptin, used to treat metastatic diseases of patients
• Although the innovator of Trastuzumab witnessed a huge success in the metastatic treatment process, the crowd’s attention turned towards the application of the biosimilar medicine in an adjuvant setting mostly provided after breast cancer surgery. The adjuvant Trastuzumab found similar success as in the metastatic setting. Consequently, the biosimilar drug progressed the tumour shrinkage given before neoadjuvant therapy. The developers of the oncology biosimilars at Genentech led the development of Herceptin through their efforts and research
• The monoclonal antibody was developed as a life-saving therapy for women, reducing the risk of recurrence of metastatic and early-stage diseases. The major benefit associated with the biosimilar medicine was their lower prices, suggested by the innovator of Trastuzumab
• The biosimilar medicine received its approval from the World Health Organization with the same motive of making an affordable life-saving treatment for women dealing with breast cancer. It is the most common cancer that takes place in women and is expensive at the same time. However, WHO approved the medicine to make this expensive treatment affordable for everyone. In 2022 there will be 1.9 million new cases estimated to occur by the end of the year. 2.3 million breast cancer cases were contracted in 2020. 6,85,000 died due to lack of access to affordable treatment and late diagnosis
• WHO included the monoclonal antibody, i.e., Trastuzumab, in its essential medicines list in 2015 as part of the necessary treatment for 20% of breast cancer. The drug has shown great efficacy in recovery from the early stage of breast cancer and sometimes in advanced forms of the disease
• The qualification of Trastuzumab by WHO is a ray of hope for women across the globe. Many women in different cultures face gender disparity while accessing health services. In undeveloped countries, the lack of access to treatment and the heavy cost of medicinal products burden the patients. A low-cost breast cancer treatment should be the right for every woman. The innovator of Trastuzumab, i.e., the Genentech company, derived the total cost of the biosimilar medicine of $20,000, putting it far away from the reach of several women. The trastuzumab biosimilar’s version is 65% cheaper in the listing of WHO than the developers
• Biosimilars are an essential option to provide easy access to high-cost treatments, especially for women dealing with breast cancer. Although, the treatment with biosimilar medicine has certain limitations in the medical community regarding its extrapolation, safety, immunogenicity and switching treatment regimens. The qualification of Trastuzumab by WHO assures all countries that they buy a high-quality health product
• According to a recent study, many women didn’t initiate their cancer treatment due to the high treatment cost, being the major barrier to not getting the treatment within one year of diagnosis. Shedding light on the subject matter, WHO says the number diagnosed with breast cancer will rise to 3.1 million by 2040, with a great increase in middle and low-income countries. The availability of biosimilar medicine has made the innovative treatments affordable for everyone with its decreased prices, keeping the safety of people in mind

Conclusion 

Breast cancer is the most common form of cancer in women due to genetic factors, obesity, consuming too much alcohol, etc. Breast cancer treatment is generally very high and unaffordable for many women. The innovator of Trastuzumab and the approval of the biosimilar medicine by WHO removed the cost-related concern for breast cancer treatment in women. It is the first biosimilar medicine to get WHO approval for the treatment, ensuring the purchase of healthy medicinal products for low and middle-income countries to provide affordable treatment to patients in their regions.