FDA's Approval of the First Biosimilar to Bevacizumab.
review · Level V
Where this comes from
- Record sourced from PubMed, PMID 29743182.
- Also identified by DOI 10.1158/1078-0432.CCR-18-0566.
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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. <i>Clin Cancer Res; 24(18); 4365-70. ©2018 AACR</i>.
Medical subject headings
- Bevacizumab
- Biosimilar Pharmaceuticals
- Carcinoma, Non-Small-Cell Lung
- Drug-Related Side Effects and Adverse Reactions