FDA's Approval of the First Biosimilar to Bevacizumab

Sandra J Casak; Steven J Lemery; Jee Chung; Chana Fuchs; Sarah J Schrieber; Edwin C Y Chow; Weishi Yuan; Lisa Rodriguez; Thomas Gwise; Anne Rowzee; Sue Lim; Patricia Keegan; Amy E McKee; Richard Pazdur

doi:10.1158/1078-0432.CCR-18-0566

FDA's Approval of the First Biosimilar to Bevacizumab

Clin Cancer Res. 2018 Sep 15;24(18):4365-4370. doi: 10.1158/1078-0432.CCR-18-0566. Epub 2018 May 9.

Authors

Sandra J Casak¹, Steven J Lemery², Jee Chung³, Chana Fuchs³, Sarah J Schrieber⁴, Edwin C Y Chow⁴, Weishi Yuan⁵, Lisa Rodriguez⁵, Thomas Gwise⁵, Anne Rowzee⁶, Sue Lim⁶, Patricia Keegan², Amy E McKee², Richard Pazdur^{2

7}

Affiliations

¹ Office of Hematology and Oncology Products, U.S. Food and Drug Administration, Silver Spring, Maryland. Sandra.casak@fda.hhs.gov.
² Office of Hematology and Oncology Products, U.S. Food and Drug Administration, Silver Spring, Maryland.
³ Office of Biotechnology Products, U.S. Food and Drug Administration, Silver Spring, Maryland.
⁴ Office of Clinical Pharmacology, U.S. Food and Drug Administration, Silver Spring, Maryland.
⁵ Office of Biostatistics, U.S. Food and Drug Administration, Silver Spring, Maryland.
⁶ Therapeutic Biologics and Biosimilar Staff, U.S. Food and Drug Administration, Silver Spring, Maryland.
⁷ Oncology Center of Excellence, U.S. Food and Drug Administration, Silver Spring, Maryland.

PMID: 29743182
DOI: 10.1158/1078-0432.CCR-18-0566

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.

MeSH terms

Bevacizumab / pharmacokinetics
Bevacizumab / therapeutic use*
Biosimilar Pharmaceuticals / adverse effects
Biosimilar Pharmaceuticals / pharmacokinetics
Biosimilar Pharmaceuticals / therapeutic use*
Carcinoma, Non-Small-Cell Lung / drug therapy*
Carcinoma, Non-Small-Cell Lung / epidemiology
Carcinoma, Non-Small-Cell Lung / genetics
Drug Approval
Drug-Related Side Effects and Adverse Reactions / classification
Drug-Related Side Effects and Adverse Reactions / epidemiology*
Drug-Related Side Effects and Adverse Reactions / pathology
Humans
Randomized Controlled Trials as Topic
United States
Vascular Endothelial Growth Factor A / genetics

Substances

Biosimilar Pharmaceuticals
VEGFA protein, human
Vascular Endothelial Growth Factor A
Bevacizumab