FDA's Approval of the First Biosimilar to Bevacizumab

被引：29

作者：

Casak, Sandra J. ^{[1
]}

Lemery, Steven J. ^{[1
]}

Chung, Jee ^{[2
]}

Fuchs, Chana ^{[2
]}

Schrieber, Sarah J. ^{[3
]}

Chow, Edwin C. Y. ^{[3
]}

Yuan, Weishi ^{[4
]}

Rodriguez, Lisa ^{[4
]}

Gwise, Thomas ^{[4
]}

Rowzee, Anne ^{[5
]}

Lim, Sue ^{[5
]}

Keegan, Patricia ^{[1
]}

McKee, Amy E. ^{[1
]}

Pazdur, Richard ^{[1
,6
]}

机构：

[1] US FDA, Off Hematol & Oncol Prod, Silver Spring, MD USA

[2] US FDA, Off Biotechnol Prod, Silver Spring, MD USA

[3] US FDA, Off Clin Pharmacol, Silver Spring, MD USA

[4] US FDA, Off Biostat, Silver Spring, MD USA

[5] US FDA, Therapeut Biol & Biosimilar Staff, Silver Spring, MD USA

[6] US FDA, Oncol Ctr Excellence, Silver Spring, MD USA

来源：

CLINICAL CANCER RESEARCH | 2018年 / 24卷 / 18期

关键词：

CELL LUNG-CANCER; ENDOTHELIAL GROWTH-FACTOR; RANDOMIZED PHASE-II; CARBOPLATIN; PACLITAXEL; TRIAL; SAFETY;

D O I：

10.1158/1078-0432.CCR-18-0566

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 ;

摘要：

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. (C) 2018 AACR.

引用

页码：4365 / 4370

页数：6

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