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 FDA approved ABP215 (MVASI, bevacizumab-awwb; Amgen) as a biosimilar to U.S.-licensed Avastin (bevacizumab; Genentech) based on an extensive comparative analyti...

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Published inClinical cancer research Vol. 24; no. 18; pp. 4365 - 4370
Main Authors Casak, Sandra J., Lemery, Steven J., Chung, Jee, Fuchs, Chana, Schrieber, Sarah J., Chow, Edwin C.Y., Yuan, Weishi, Rodriguez, Lisa, Gwise, Thomas, Rowzee, Anne, Lim, Sue, Keegan, Patricia, McKee, Amy E., Pazdur, Richard
Format Journal Article
LanguageEnglish
Published United States 15.09.2018
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Summary: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.
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ISSN:1078-0432
1557-3265
1557-3265
DOI:10.1158/1078-0432.CCR-18-0566