Related Experiment Videos
FDA's Approval of the First Biosimilar to Bevacizumab
Sandra J Casak1, Steven J Lemery2, Jee Chung3
1Office of Hematology and Oncology Products, U.S. Food and Drug Administration, Silver Spring, Maryland. Sandra.casak@fda.hhs.gov.
Abstract:
Passage of the Biologics Price Competition and Innovation Act of 2009 created an abbreviated licensure pathway for biosimilar products. The FDA approved ABP215 (MVASI, bevacizumab-awwb; Amgen) as a biosimilar to U.S.-licensed Avastin (bevacizumab; Genentech) based on an extensive comparative analytic 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 U.S.-licensed Avastin, without the need of additional clinical studies. Clin Cancer Res; 24(18); 4365-70. ©2018 AACR.