FDA approves first cancer biosimilar
The US Food and Drug Administration has approved Amgen’s Mvasi (bevacizumab-awwb) as a biosimilar to Roche/Genentech’s Avastin (bevacizumab) for the treatment of multiple types of cancer, making it the first biosimilar approved in the country for the treatment of cancer. Mvasi is approved for the treatment of adult patients with certain colorectal, lung, brain, kidney and cervical cancers, and could not cut into sales of Avastin, which tottalled $6.7 billion last year. Amgen and its partner Allergan have also filed the drug for regulatory approval in the EU.