FDA's Approval of the First Biosimilar to Bevacizumab
FDA's Approval of the First Biosimilar to Bevacizumab
复制标题
DOI：
10.1158/1078-0432.ccr-18-0566
复制
发表时间：
2018-09-15
影响因子：
11.5
通讯作者：
Pazdur, Richard
中科院分区：
文献类型：
--
作者：
Casak, Sandra J.;Lemery, Steven J.;Pazdur, Richard
2009年《生物制品价格竞争和创新法案》的通过为生物类似药产品创造了一个简化的许可证途径。FDA批准ABP 215（MVASI，贝伐珠单抗-阿伐单抗;安进公司）作为美国-许可的安维汀（贝伐单抗; Genentech）基于广泛的比较分析表征、在健康受试者中的药代动力学相似性研究中获得的数据以及在非小细胞肺癌患者中的比较临床研究。生物相似性的全部证据支持外推数据，以支持作为美国其他已批准适应症的生物类似药的许可。获得批准的安维汀，无需额外的临床研究。(C)2018年AACR。
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.