Amgen and Allergan’s anti-cancer biosimilar Mvasi receives FDA approval


The US Food and Drug Administration (FDA) has approved Mvasi (bevacizumab-awwb) for the treatment of five types of cancer.

Co-developed by Amgen and Allergan, Mvasi is the first anti-cancer biosimilar to be approved by the FDA and is largely similar to Avastin (bevacizumab).

Mvasi can be used in combination with chemotherapy for non-squamous non-small-cell lung cancer (NSCLC), metastatic colorectal cancer (mCRC), glioblastoma, metastatic renal cell carcinoma in combination with interferon alfa, and for persistent, recurrent, or metastatic carcinoma of the cervix.

Amgen research and development executive vice-president Dr 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 US.

“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.”

"The approval of Mvasi marks a significant milestone for healthcare practitioners and patients as the first anti-cancer biosimilar approved in the US."

Mvasi is a biosimilar to bevacizumab, a recombinant immunoglobulin G1 (IgG1) monoclonal antibody (mAb) that binds to vascular endothelial growth factor (VEGF) and inhibits the interaction of VEGF with its receptors, VEGF receptor-1 and VEGF receptor-2.

This inhibits establishment of new blood vessels that are essential for the maintenance and growth of solid tumours.

The current FDA approval is based on a comprehensive data package that revealed the similarity of Mvasi with bevacizumab, with no clinically meaningful differences in terms of the efficacy, safety and immunogenicity between the products.

Also, the clinical studies included data from a Phase III trial conducted on patients with NSCLC.