Part 1: Physicochemical characterization of bevacizumab in undiluted 25 mg/mL drug product solutions: Comparison of originator with a biosimilar candidate-Reference-Cited by-同舟云学术

Part 1: Physicochemical characterization of bevacizumab in undiluted 25 mg/mL drug product solutions: Comparison of originator with a biosimilar candidate

Published:2019-10 Issue: Volume:175 Page:112742
ISSN:0731-7085
Container-title:Journal of Pharmaceutical and Biomedical Analysis
language:en
Short-container-title:Journal of Pharmaceutical and Biomedical Analysis

Author:

Arvinte Tudor,Palais Caroline,Poirier Emilie,Cudd Amelia,Rajendran Shanthi,Brokx Stephen,Dowd Jason

Publisher

Elsevier BV

Subject

Clinical Biochemistry,Spectroscopy,Drug Discovery,Pharmaceutical Science,Analytical Chemistry

Reference28 articles.

1. FDA-Approved Biosimilar Products,2019

2. European Public Assessment Reports. Biosimilars,2019

3. GABI Journal. Biosimilars of bevacizumab,2019

4. Analytical and functional similarity of Amgen biosimilar ABP 215 to bevacizumab;Seo;mAbs,2018

5. Biologics Price Competition and Innovation Act of 2009, H.R.3590 Patient Protection and Affordable Care Act (Enrolled Bill [Final as Passed Both House and Senate] - ENR) Sec. 7002 Approval Pathway for Biosimilar Biological Products,2019

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