Reports of Radiotherapy and Oncology

Published by: Kowsar

Methodological Consideration for Clinical Development of Bevacizumab Biosimilar Candidate

Kambiz Novin 1 , * and Nafiseh Mortazavi 2
Authors Information
1 Department of Radiotherapy and Oncology, Haft-e-Tir Hospital, Faculty of Medicine, Iran University of Medical Sciences, Tehran, Iran
2 Department of Pathology, Faculty of Medicine, Shahid Beheshti University of Medical Sciences, Tehran, Iran
Article information
  • Reports of Radiotherapy and Oncology: In Press (In Press); e91577
  • Published Online: March 17, 2019
  • Article Type: Letter
  • Received: March 13, 2019
  • Accepted: March 14, 2019
  • DOI: 10.5812/rro.91577

To Cite: Novin K, Mortazavi N. Methodological Consideration for Clinical Development of Bevacizumab Biosimilar Candidate, Rep Radiother Oncol. Online ahead of Print ; In Press(In Press):e91577. doi: 10.5812/rro.91577.

Copyright © 2019, Reports of Radiotherapy and Oncology. This is an open-access article distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 International License (http://creativecommons.org/licenses/by-nc/4.0/) which permits copy and redistribute the material just in noncommercial usages, provided the original work is properly cited.
Footnotes
References
  • 1. U.S. Department of Health and Human Services; Center for Drug Evaluation and Research (CDER); Center for Biologics Evaluation and Research (CBER). Scientific considerations in demonstrating bio similarity to a reference product. Guidance for industry. Food and Drug Administration; 2015.
  • 2. European Medicines Agency Evaluation of Medicines for Human Use. Guideline on similar biological medicinal products. London: Committee for Medicinal Products for Human Use (CHMP); 2005.
  • 3. He K, Chen H, Gwise T, Casak S, Lemery S, Keegan P, et al. Statistical considerations in evaluating a biosimilar product in an oncology clinical study. Clin Cancer Res. 2016;22(21):5167-70. doi: 10.1158/1078-0432.CCR-16-1010. [PubMed: 27582485].
  • 4. Heinzmann D. Methodological considerations for clinical equivalence of bevacizumab biosimilars. Ann Oncol. 2016;27. doi: 10.1093/annonc/mdw603.016.
  • 5. World Health Organization. Expert committee on biological standardization. Guidelines on evaluation of similar bio therapeutic products (SBPs). World Health Organization; 2009.
  • 6. Eropean Medicine Agency. Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: Non-clinical and clinical issues. Committee for Medicinal Products for Human Use (CHMP); 2014.
  • 7. PBRER. Roche data on file. Safety Report; 2017.

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