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Alsamil AM, Giezen TJ, Egberts TC, et al. Comparison of consistency and complementarity of reporting biosimilar quality attributes between regulatory and scientific communities: An adalimumab case study. Biologicals. 2021;69:30-37doi: 10.1016/j.biologicals.2020.12.003.
Alsamil, A. M., Giezen, T. J., Egberts, T. C., Leufkens, H. G., & Gardarsdottir, H. (2021). Comparison of consistency and complementarity of reporting biosimilar quality attributes between regulatory and scientific communities: An adalimumab case study. Biologicals : journal of the International Association of Biological Standardization, 6930-37. https://doi.org/10.1016/j.biologicals.2020.12.003
Alsamil, Ali M, et al. "Comparison of consistency and complementarity of reporting biosimilar quality attributes between regulatory and scientific communities: An adalimumab case study." Biologicals : journal of the International Association of Biological Standardization vol. 69 (2021): 30-37. doi: https://doi.org/10.1016/j.biologicals.2020.12.003
Alsamil AM, Giezen TJ, Egberts TC, Leufkens HG, Gardarsdottir H. Comparison of consistency and complementarity of reporting biosimilar quality attributes between regulatory and scientific communities: An adalimumab case study. Biologicals. 2021 Jan;69:30-37. doi: 10.1016/j.biologicals.2020.12.003. Epub 2021 Jan 13. PMID: 33454195.
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Biologicals. 2021 Jan;69:30-37. doi: 10.1016/j.biologicals.2020.12.003. Epub 2021 Jan 13.

Comparison of consistency and complementarity of reporting biosimilar quality attributes between regulatory and scientific communities: An adalimumab case study.

Biologicals : journal of the International Association of Biological Standardization

Ali M Alsamil, Thijs J Giezen, Toine C Egberts, Hubert G Leufkens, Helga Gardarsdottir

Affiliations

  1. Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute of Pharmaceutical Sciences, Faculty of Science, Utrecht University, Utrecht, the Netherlands; Pharmaceutical Product Evaluation Directorate, Drug Sector, Saudi Food and Drug Authority, Riyadh, Saudi Arabia.
  2. Foundation Pharmacy for Hospitals in Haarlem, Haarlem, the Netherlands; Department of Clinical Pharmacy, Spaarne Gasthuis, Haarlem, the Netherlands.
  3. Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute of Pharmaceutical Sciences, Faculty of Science, Utrecht University, Utrecht, the Netherlands; Department of Clinical Pharmacy, University Medical Center Utrecht, Utrecht, the Netherlands.
  4. Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute of Pharmaceutical Sciences, Faculty of Science, Utrecht University, Utrecht, the Netherlands.
  5. Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute of Pharmaceutical Sciences, Faculty of Science, Utrecht University, Utrecht, the Netherlands; Department of Clinical Pharmacy, University Medical Center Utrecht, Utrecht, the Netherlands; Department of Pharmaceutical Sciences, University of Iceland, Reykjavik, Iceland. Electronic address: [email protected].

PMID: 33454195 DOI: 10.1016/j.biologicals.2020.12.003

Abstract

Biosimilar approval relies on the comparability of quality attributes (QAs), for which information can be derived from regulatory or scientific communities. Limited information is known about whether these sources are consistent with or complementary to each other. The consistency and complementarity of QA reporting in biosimilarity assessments for adalimumab biosimilars approved by the European Medicines Agency in European public assessment reports (EPARs) and scientific publications was assessed. A classification of 77 different QAs (53 structural and 24 functional attributes) was used to assess the types of and information on QAs reported. Six adalimumab biosimilars were analyzed, for which the number of QAs reported in EPARs and publications varied (range = 47 [61%]-60 [78%]). The proportion of QAs consistently reported in both sources varied (range = 28%-75%) among biosimilars; functional QAs (mean = 21 QAs [88%]; range = 19-23) were more consistently reported than structural QAs (mean = 33 QAs [62%]; range = 27-34). The EPARs frequently reported biosimilarity interpretation without providing test results (9-57 QAs in EPARs versus 0-8 QAs in publications), whereas publications frequently reported both test results and interpretations (13-40 QAs in publications versus 0-3 QAs in EPARs). Both sources provided information on the biosimilarity of QAs in a complementary manner and the same biosimilarity interpretation of test results for reported QAs (mean = 90%; range = 78%-100%), with a small discrepancy in biosimilarity interpretations of a few clinically relevant QAs related to post-translation modifications and biological activity. Comprehensive reporting of QAs can contribute to an improved understanding of the role of structural and functional attributes in establishing biosimilarity and the mechanism of action of biological substances in general.

Copyright © 2020 The Author(s). Published by Elsevier Ltd.. All rights reserved.

Keywords: Adalimumab; Biological drugs; Biosimilarity; Biosimilars; Comparability; European public assessment reports (EPARs); Monoclonal antibody; Quality attributes

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