Avastin (Bevacizumab) in Dano Health
Bevacizumab with the trade name Avastin was the first available angiogenesis inhibitor in the United States. It is a “monoclonal antibody” and “anti-angiogenesis” drug used to treat a number of types of cancers by interfering with the growth and spread of cancer cells in the body and it is also used for a specific eye disease. It is usually given as part of a combination of cancer medicines.
According to the World Health Organization’s List of Essential Medicines, Bevacizumab is the most effective and safe medicines needed in a health system.
In 1971, Judah Folkman hypothesized that stopping angiogenesis might be useful in controlling cancer growth. Later, scientist Napoleone Ferrara in the laboratory of Genentech worked on the discovery of Human Vascular Endothelial Growth Factor (VEGF); VEGF is a protein that stimulated blood vessel growth. At the end of the study, Ferrara found out that antibodies against VEGF inhibit tumor growth in mice and validated the hypothesis of Judah Folkman. This study was the base of Bevacizumab development.
In 2004: It was approved in the United States for combination use with standard chemotherapy for metastatic colon cancer
In 2006: FDA Approves Avastin in Combination With Chemotherapy for First-Line Treatment of Most Common Type of Lung Cancer
In 2008: FDA approved bevacizumab for breast cancer subject to further studies. But after further study, The FDA’s advisory panel had recommended against approval.
In 2009: FDA Grants Accelerated Approval of Avastin for Brain Cancer (Glioblastoma) That Has Progressed Following Prior Therapy
In 2011: Genentech requested a hearing granted in June 2011. The FDA ruled to withdraw the breast cancer indication in November 2011. Genentech required the FDA approval to market a drug for that indication.
In 2017: FDA Granted Genentech’s Avastin Full Approval for Most Aggressive Form of Brain Cancer.
The patents on Avastin will expire in the US in 2019 and in Europe in 2022.
Bevacizumab is approved to be used alone or with other drugs to treat:
- patients with persistent, recurrent or metastatic cervical cancer
- patients with stage III or IV epithelial ovarian, fallopian tube, or primary peritoneal cancer following initial surgical resection
- patients with platinum-resistant recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer who received no more than 2 prior chemotherapy regimens
- metastatic renal cell carcinoma
- patients with unresectable, locally advanced, recurrent or metastatic non–squamous non–small cell lung cancer
- Recurrent glioblastoma in adults.
- patients with metastatic colorectal cancer who have progressed on a first-line Avastin-containing regimen.
Avastin is not indicated for the adjuvant treatment of colon cancer. It is also being studied for the treatment of other types of cancer.
In the case of bevacizumab, a recombinant humanized monoclonal antibody, the mechanism of action is inhibition of a cell surface protein called vascular endothelial growth factor (VEGF). The function of VEGF is to help tumors to form new blood vessels; blocking VEGF stops cancer from developing its own blood supply. So that tumor’s supply of oxygen and nutrients will be reduced and growth and survival of tumors will be stopped.
Angiogenesis inhibitors or anti-angiogenic are terms that used for drugs preventing the growth of blood vessels.
According to the preclinical models, Avastin directly binds Vascular Endothelial Growth Factor (VEGF) to inhibit angiogenesis.
These models have shown that Avastin may have certain effects to inhibit tumor growth and development:
|Proposed effects||Potential effect on vessels||Potential impact on tumor|
|Anti-vascular||Regression of existing tumor vasculature||Reduction of tumor size|
|Anti-angiogenesis||Inhibition of new and recurrent tumor vessel growth||Inhibition of tumor growth|
In July 2014, two pharming companies, PlantForm, and PharmaPraxis in collaboration with the Fraunhofer Center for Molecular Biology announced their plans to commercialize a biosimilar version of bevacizumab made by the use a tobacco expression system.
Biotech giant Amgen and partner Allergan produced Mvasi, Bevacizumab biosimilar. In 2017 Amgen’s biosimilar (generic name bevacizumab-Awwb, product name Mvasi) approved by the US FDA for the treatment of carcinoma of the colon or rectum, breast cancer, non-small cell lung cancer, renal cell cancer, epithelial ovarian, fallopian tube or primary peritoneal cancer and carcinoma of the cervix.
Biocon and partner Mylan have a version under review in the EU.
Manufacturers including Samsung Bioepis, Boehringer Ingelheim, Pfizer, AryoGen Biopharma, Reliance Life Sciences, and Fujifilm Kyowa Kirin Biologics have Avastin biosimilars in phase 3.
It should also be noted that Dano Health as a clinical trial product distributor can provide Avastin for the companies who want to search on it.
The second leading cause of mortality among cancer patients in the world is Colorectal cancer (CRC); It is also the third most diagnosed cancer globally and thus represents a huge burden on healthcare systems.
Avastin claimed its first approval in colorectal cancer in 2004 and has steadily added new indications since then and recently approved by European to use alongside Tarceva for patients with EGFR-positive non-small cell lung cancer.
According to the new PharmaPoint Drug Evaluation report of GlobalData, currently, Avastin is Roche’s second biggest-selling drug and routinely swapping places with breast cancer stalwart Herceptin.
Next year, the combination of Avastin plus Tecentriq could be submitted to regulators if studies in renal cell carcinoma and non-small cell lung cancer go according to plan.
Due to rising demand for ovarian, colorectal, lung and cervical cancer, particularly in Europe and emerging markets, Avastin sales rose 9% in 2015. But Avastin’s upward trajectory is likely to change because biosimilar versions of the drug are hitting the market. These biosimilars are already on the market, notably in India and Russia but they will have a fight on their hands with Roche. Roche has patent protection for Avastin in the U.S. until 2019 and in Europe until 2022. Avastin price for a treatment period is almost £21,000 per patient in the UK and nearly 6,500 people per year could be eligible for the drug. Avastin is marketed in Turkey under the trade name Altuzan. Dano Health as a Turkish pharmaceutical distributor alongside other Avastin suppliers and Altuzan suppliers are expecting the brand to lose a couple of billion dollars by 2022 but keeping it among the top 10 cancer drugs.