A Biosimilar Drug Receives FDA Approval for Cancer Treatment for the First Time

The American Food and Drug Administration FDA approved the first biosimilar drug for use in cancer treatments. Mvasi, a biosimilar form of the cancer drug Avastin (available in our country under the name Altuzan), will be used to treat colorectal, lung, brain, kidney and uterine cancers.

Mvasi contains the active ingredient bevacizumab-awwb . Bevacizumab blocks the signal for the formation of new blood vessels needed for tumor growth. In other words, it prevents the formation of new vessels that supply the increased oxygen and nutrient needs of uncontrollably multiplying cancer cells. Bevacizumab is therefore an antiangiogenic cancer drug.

- Related topic: Angiogenesis - what is the importance of new blood vessel formation for cancer and its treatments?

What is a biosimilar?

A biosimilar is a form of drug produced using biotechnology that has the same effect as the reference drug and is highly similar chemically. When the original drug’s patent expires, various pharmaceutical companies produce biosimilars using the same biotechnological methods at a lower cost.

- Related topic: What is a generic (equivalent) drug? What does biosimilar mean?

For which cancer types did Mvasi receive approval?

• Metastatic large bowel (colorectal) cancer
• Non-small cell lung cancers, nonsquamous subtypes
• The brain tumor glioblastoma (GBM)
• Metastatic renal cell carcinoma (kidney cancer)
• Cervical cancer

Approval of this drug was granted after reviewing data from meticulous research. This research included structural and functional analysis of the biosimilar, experimental animal studies, human pharmacokinetic and pharmacodynamic data, immunological analyses, and safety and efficacy clinical trials . All these analyses showed that Mvasi is biosimilar to Altuzan.

What side effects does Mvasi have?

Its side effects are similar to those of Altuzan. Commonly reported side effects are nosebleeds, headache, hypertension, nasal inflammation, protein leakage into the urine, taste disturbances, dry skin, rectal bleeding, excessive tear production, lower back pain and skin sensitivity.

Like Altuzan, Mvasi carries a substantial risk of perforation of the stomach and intestines. Patients should not receive Mvasi for 4 weeks before and after surgery. Mvasi should not be given to patients at risk of bleeding or those coughing up blood.

So what does this mean for cancer?

• The main advantage of biosimilars is their substantially lower production cost. Producing a biosimilar is 25 percent cheaper than producing the original drug.
• Biosimilars may reduce healthcare expenditure and also make effective cancer treatments easier to access.
• Biosimilars are becoming an important market worldwide. In 2017, the biosimilar market is expected to reach 3.99 billion dollars.