Regulatory Affairs

FDA approves biosimilar of Avastin to treat five types of cancer

PBR Staff Writer Published 15 September 2017

Amgen and Allergan have secured approval from the US Food and Drug Administration (FDA) for Mvasi (bevacizumab-awwb), a biosimilar to Roche's Avastin, to treat five types of cancer.

It is the first biosimilar approved in the US to treat cancer.

Mvasi has been approved to treat certain colorectal, brain, lung, kidney and cervical cancers in adult patients.

The drug also became the first bevacizumab biosimilar to be approved by the US regulator.

Amgen research and development executive vice president Sean E. Harper said: “The approval of MVASI marks a significant milestone for healthcare practitioners and patients as the first anti-cancer biosimilar approved in the United States.

“With decades of experience in oncology and biologics, Amgen continues to expand its biosimilar and oncology portfolios, and MVASI has the potential to advance access to high-quality, targeted cancer therapy.”

Mvasi can now be used for the treatment of non-squamous non-small cell lung cancer (NSCLC) in combination with chemotherapy.

It can be used for treating metastatic colorectal cancer (mCRC) also in combination with chemotherapy.

Mvasi in combination with interferon alfa has been approved for the treatment of glioblastoma and metastatic renal cell carcinoma.

It has also been approved for treating persistent, recurrent, or metastatic carcinoma of the cervix in combination with chemotherapy.

Mvasi according to the FDA has been approved as a biosimilar but not as an interchangeable product. Its approval was based on the totality of evidence presented by its developers which includes structure, function, toxicity, pharmacodynamics, pharmacokinetics, immunogenicity along with clinical safety and efficacy.

FDA Commissioner Scott Gottlieb said: “Bringing new biosimilars to patients, especially for diseases where the cost of existing treatments can be high, is an important way to help spur competition that can lower healthcare costs and increase access to important therapies.

“We’ll continue to work hard to ensure that biosimilar medications are brought to the market quickly, through a process that makes certain that these new medicines meet the FDA’s rigorous gold standard for safety and effectiveness.”

Mvasi is a recombinant immunoglobulin G1 (IgG1) monoclonal antibody (mAb). The bevacizumab biosimilar functions by binding to vascular endothelial growth factor (VEGF) and thereby slowing down the interaction of VEGF with its receptors, VEGF receptor-1 and VEGF receptor-2.

As a result, Mvasi blocks establishment of new blood vessels that are required for the maintenance and growth of solid tumors.

Image: Allergan site in Irvine, California. Photo: courtesy of ALLERGAN.