FDA's Approval of the First  Biosimilar to Bevacizumab

Passage of the Biologics Price Competition and Innovation Act of 2009 created an abbreviated licensure pathway for biosimilar products. The Food and Drug Administration approved ABP215 (MVASI, bevacizumab-awwb, Amgen) as a biosimilar to US-licensed Avastin (bevacizumab, Genentech) based on an extensive comparative analytical characterization, data obtained in a pharmacokinetic similarity study in healthy subjects, and a comparative clinical study in patients with non-small cell lung cancer. The totality of the evidence for biosimilarity supported extrapolation of the data to support licensure as a biosimilar for other approved indications of US-licensed Avastin, without the need of additional clinical studies.