Open Access
Numéro
Med Sci (Paris)
Volume 35, Numéro 12, Décembre 2019
Anticorps monoclonaux en thérapeutique
Page(s) 1146 - 1152
Section Les anticorps biosimilaires
DOI https://doi.org/10.1051/medsci/2019215
Publié en ligne 6 janvier 2020
  1. Reichert JM, Beck A. European medicines agency workshop on biosimilar monoclonal antibodies. MAbs 2009 ; 1: 394–416. [CrossRef] [PubMed] [Google Scholar]
  2. Beck A, Reichert JM. Approval of the first biosimilar antibodies in Europe: a major landmark for the biopharmaceutical industry. MAbs 2013 ; 5: 621–623. [CrossRef] [PubMed] [Google Scholar]
  3. Ayoub D, Jabs W, Resemann A, et al. Correct primary structure assessment and extensive glyco-profiling of cetuximab by a combination of intact, middle-up, middle-down and bottom-up ESI and MALDI mass spectrometry techniques. MAbs 2013 ; 699–710. [CrossRef] [PubMed] [Google Scholar]
  4. Gahoual R, Biacchi M, Chicher J, et al. Monoclonal antibodies biosimilarity assessment using transient isotachophoresis capillary zone electrophoresis-tandem mass spectrometry. MAbs 2014 ; 6: 1464–1473. [CrossRef] [PubMed] [Google Scholar]
  5. Beck A, Wagner-Rousset E, Wurch T, et al. Anticorps thérapeutiques et dérivés: une palette de structures pour une pléthore d’indications. Quel format et quelle glycosylation choisir ? Pour quelles applications ?. Med Sci (Paris) 2009 ; 25: 1024–1032. [CrossRef] [EDP Sciences] [PubMed] [Google Scholar]
  6. Beck A.. Biosimilar, biobetter and next generation therapeutic antibodies. MAbs 2011 ; 3: 107–110. [CrossRef] [PubMed] [Google Scholar]
  7. Beck A, Sanglier-Cianférani S, Van Dorsselaer A. Biosimilar, biobetter, and next generation antibody characterization by mass spectrometry. Anal Chem 2012 ; 84: 4637–4646. [CrossRef] [PubMed] [Google Scholar]
  8. Beck A, Debaene F, Diemer H, et al. Cutting-edge mass spectrometry characterization of originator, biosimilar and biobetter antibodies. J Mass Spectrom 2015 ; 50: 285–297. [CrossRef] [PubMed] [Google Scholar]
  9. Ambrogelly A, Gozo S, Katiyar A, et al. Analytical comparability study of recombinant monoclonal antibody therapeutics. MAbs 2018 ; 10: 513–538. [CrossRef] [PubMed] [Google Scholar]
  10. van Aerts L, De Smet K, Reichmann G, et al. Biosimilars entering the clinic without animal studies. A paradigm shift in the European Union. MAbs 2014; 6: 1155–62. [CrossRef] [PubMed] [Google Scholar]
  11. Rahalkar H, Cetintas HC, Salek S. Quality, non-clinical and clinical considerations for biosimilar monoclonal antibody development: EU, WHO, USA, Canada, and BRICS-TM regulatory guidelines. Front Pharmacol 2018; 9. [Google Scholar]
  12. Lee KH, Lee J, Bae JS, et al. Analytical similarity assessment of rituximab biosimilar CT-P10 to reference medicinal product. MAbs 2018 ; 10: 380–396. [CrossRef] [PubMed] [Google Scholar]
  13. Nupur N, Chhabra N, Dash R, et al. Assessment of structural and functional similarity of biosimilar products: Rituximab as a case study. MAbs 2018 ; 10: 143–158. [CrossRef] [PubMed] [Google Scholar]
  14. Lee N, Lee JAJ, Yang H, et al. Evaluation of similar quality attribute characteristics in SB5 and reference product of adalimumab. MAbs 2018 ; 11: 129–144. [CrossRef] [PubMed] [Google Scholar]
  15. Hassett B, Scheinberg M, Castañeda-Hernández G, et al. Variability of intended copies for etanercept (Enbrel®): data on multiple batches of seven products. MAbs 2018 ; 10: 166–176. [CrossRef] [PubMed] [Google Scholar]
  16. Beck A, Wagner-Rousset E, Bussat MC, et al. Trends in glycosylation, glycoanalysis and glycoengineering of therapeutic antibodies and Fc-fusion proteins. Curr Pharm Biotechnol 2008 ; 9: 482–501. [CrossRef] [PubMed] [Google Scholar]
  17. Largy E, Cantais F, Van Vyncht G, et al. Orthogonal liquid chromatography-mass spectrometry methods for the comprehensive characterization of therapeutic glycoproteins, from released glycans to intact protein level. J Chromatogr A 2017 ; 1498: 128–146. [CrossRef] [PubMed] [Google Scholar]
  18. Fang J, Doneanu C, Alley WRJ, et al. Advanced assessment of the physicochemical characteristics of Remicade® and Inflectra® by sensitive LC/MS techniques. MAbs 2016 ; 8: 1021–1034. [CrossRef] [PubMed] [Google Scholar]
  19. Lee C, Jeong M, Lee JAJ, et al. Glycosylation profile and biological activity of Remicade® compared with Flixabi® and Remsima®. MAbs 2017 ; 9: 968–977. [CrossRef] [PubMed] [Google Scholar]
  20. Brachet G, Respaud R, Arnoult C, et al. Increment in drug loading on an antibody-drug conjugate increases its binding to the human neonatal Fc receptor in vitro. Mol Pharm 2016 ; 13: 1405–1412. [CrossRef] [PubMed] [Google Scholar]
  21. Seo N, Polozova A, Zhang M, et al. Analytical and functional similarity of Amgen biosimilar ABP 215 to bevacizumab. MAbs 2018 ; 10: 678–691. [CrossRef] [PubMed] [Google Scholar]
  22. Liu J, Eris T, Li C, et al. Assessing analytical similarity of proposed amgen biosimilar ABP 501 to Adalimumab. BioDrugs 2016 ; 30: 321–338. [CrossRef] [PubMed] [Google Scholar]
  23. Magnenata L, Palmeseb A, Fremauxc C ele, et al. Demonstration of physicochemical and functional similarity between the proposed. MAbs 2017; 9: 127–39. [CrossRef] [PubMed] [Google Scholar]

Les statistiques affichées correspondent au cumul d'une part des vues des résumés de l'article et d'autre part des vues et téléchargements de l'article plein-texte (PDF, Full-HTML, ePub... selon les formats disponibles) sur la platefome Vision4Press.

Les statistiques sont disponibles avec un délai de 48 à 96 heures et sont mises à jour quotidiennement en semaine.

Le chargement des statistiques peut être long.