Literature DB >> 29743182

FDA's Approval of the First Biosimilar to Bevacizumab.

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 Pazdur2,7.   

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. ©2018 American Association for Cancer Research.

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Year:  2018        PMID： 29743182     DOI： 10.1158/1078-0432.CCR-18-0566

Source DB:  PubMed          Journal:  Clin Cancer Res        ISSN： 1078-0432            Impact factor:   12.531


  11 in total

Review 1.  What Does the Pipeline Promise about Upcoming Biosimilar Antibodies in Oncology?

Authors:  Antonia Busse; Diana Lüftner
Journal:  Breast Care (Basel)       Date:  2019-02-13       Impact factor: 2.860

2.  A comparative pharmacokinetic study of DRL_BZ, a candidate biosimilar of bevacizumab, with Avastin® (EU and US) in healthy male subjects.

Authors:  Chris Wynne; Christian Schwabe; Sonica Sachdeva Batra; Luis Lopez-Lazaro; Suresh Kankanwadi
Journal:  Br J Clin Pharmacol       Date:  2018-07-26       Impact factor: 4.335

3.  Comparison of efficacy and safety of bevacizumab biosimilar and original bevacizumab in non-squamous non-small cell lung cancer: a systematic review and meta-analysis.

Authors:  Xian Xiao; Guixing Zhang; Binxu Sun; Chaoran Wang; Xiaoqun Wang; Fanming Kong; Yingjie Jia
Journal:  Transl Cancer Res       Date:  2022-06       Impact factor: 0.496

4.  Efficacy, Safety, and Immunogenicity of HLX04 Versus Reference Bevacizumab in Combination with XELOX or mFOLFOX6 as First-Line Treatment for Metastatic Colorectal Cancer: Results of a Randomized, Double-Blind Phase III Study.

Authors:  Shukui Qin; Jin Li; Yuxian Bai; Yongqian Shu; Wei Li; Xianli Yin; Ying Cheng; Guoping Sun; Yanhong Deng; Haijun Zhong; Yunfeng Li; Xiaoping Qian; Liangming Zhang; Jingdong Zhang; Kehe Chen; Wenying Kang
Journal:  BioDrugs       Date:  2021-05-20       Impact factor: 5.807

5.  Equivalent efficacy study of QL1101 and bevacizumab on untreated advanced non-squamous non-small cell lung cancer patients: a phase 3 randomized, double-blind clinical trial.

Authors:  Tianqing Chu; Jun Lu; Minghong Bi; Helong Zhang; Wu Zhuang; Yan Yu; Jianhua Shi; Zhendong Chen; Xiaochun Zhang; Qisen Guo; Quan Liu; Huijuan Wu; Jian Fang; Yi Hu; Xiuwen Wang; Cuicui Han; Kai Li; Baohui Han
Journal:  Cancer Biol Med       Date:  2021-03-12       Impact factor: 4.248

6.  Equivalent efficacy assessment of QL1101 and bevacizumab in nonsquamous non-small cell lung cancer patients: A two-year follow-up data update.

Authors:  Jun Lu; Tianqing Chu; Hongyu Liu; Minjuan Hu; Yuqing Lou; Yanwei Zhang; Zhiqiang Gao; Wei Zhang; Xueyan Zhang; Huimin Wang; Hua Zhong; Baohui Han
Journal:  Chin J Cancer Res       Date:  2022-02-28       Impact factor: 5.087

7.  Clinical and treatment characteristics of patients treated with the first therapeutic oncology biosimilars bevacizumab-awwb and trastuzumab-anns in the US.

Authors:  Ran Jin; Reshma L Mahtani; Neil Accortt; Tatiana Lawrence; Darcie Sandschafer; Arturo Loaiza-Bonilla
Journal:  Ther Adv Med Oncol       Date:  2021-09-01       Impact factor: 8.168

8.  A randomized, double-blind, single-dose study to evaluate the biosimilarity of QL1101 with bevacizumab in healthy male subjects.

Authors:  Ya-Nan Liu; Jie Huang; Can Guo; Shuang Yang; Ling Ye; Shu-Ting Wu; Xing-Fei Zhang; Xiao-Yan Yang; Cui-Cui Han; Qi Pei; Lu Huang; Qing-Nan He; Guo-Ping Yang
Journal:  Cancer Chemother Pharmacol       Date:  2020-01-06       Impact factor: 3.333

Review 9.  Current and future roles of biosimilars in oncology practice.

Authors:  Sofia Konstantinidou; Angeliki Papaspiliou; Eleni Kokkotou
Journal:  Oncol Lett       Date:  2019-11-15       Impact factor: 2.967

10.  A pharmacokinetics study of proposed bevacizumab biosimilar MYL-1402O vs EU-bevacizumab and US-bevacizumab.

Authors:  Matthew Hummel; Tjerk Bosje; Andrew Shaw; Mark Shiyao Liu; Abhijit Barve; Mudgal Kothekar; Mark A Socinski; Cornelius F Waller
Journal:  J Cancer Res Clin Oncol       Date:  2021-04-17       Impact factor: 4.553
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