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Journal of Immunology Research
Volume 2016, Article ID 9697080, 9 pages
http://dx.doi.org/10.1155/2016/9697080
Clinical Study

New Alternatives for Autoimmune Disease Treatments: Physicochemical and Clinical Comparability of Biosimilar Etanercept

1Unidad de Investigación y Desarrollo, Probiomed S.A. de C.V., Cruce de Carreteras Acatzingo-Zumpahuacán, 52400 Tenancingo, MEX, Mexico
2Dirección Médica, Probiomed S.A. de C.V., Avenida Ejército Nacional No. 499, Colonia Granada, Delegación Miguel Hidalgo, 11520 Mexico, DF, Mexico

Received 27 February 2016; Accepted 13 April 2016

Academic Editor: Oscar Bottasso

Copyright © 2016 Mariana P. Miranda-Hernández et al. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

Linked References

  1. A. A. Sinha, M. T. Lopez, and H. O. Mcdevitt, “Autoimmune diseases: the failure of self tolerance,” Science, vol. 248, no. 4961, pp. 1380–1388, 1990. View at Publisher · View at Google Scholar · View at Scopus
  2. D. L. Jacobson, S. J. Gange, N. R. Rose, and N. M. H. Graham, “Epidemiology and estimated population burden of selected autoimmune diseases in the United States,” Clinical Immunology and Immunopathology, vol. 84, no. 3, pp. 223–243, 1997. View at Publisher · View at Google Scholar · View at Scopus
  3. J. S. Smolen, R. Landewé, F. C. Breedveld et al., “EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs,” Annals of the Rheumatic Diseases, vol. 69, no. 6, pp. 964–975, 2010. View at Publisher · View at Google Scholar · View at Scopus
  4. T. H. Page, J. J. O. Turner, A. C. Brown et al., “Nonsteroidal anti-inflammatory drugs increase TNF production in rheumatoid synovial membrane cultures and whole blood,” The Journal of Immunology, vol. 185, no. 6, pp. 3694–3701, 2010. View at Publisher · View at Google Scholar · View at Scopus
  5. M. E. Weinblatt, J. M. Kremer, A. D. Bankhurst et al., “A trial of etanercept, a recombinant tumor necrosis factor receptor: Fc fusion protein, in patients with rheumatoid arthritis receiving methotrexate,” The New England Journal of Medicine, vol. 340, no. 4, pp. 253–259, 1999. View at Publisher · View at Google Scholar · View at Scopus
  6. The European Medicines Agency, Enbrel: EPAR-Scientific Discussion, 2004.
  7. US Department of Health and Human Services and Food and Drug Administration, Guidance for Industry: Scientific Considerations in Demonstrating Biosimilarity to a Reference Product, 2012.
  8. US Department of Health and Human Services Food and Drug Administration, Guidance for Industry: Quality Considerations in Demonstrating Biosimilarity to a Reference Protein Product, US Department of Health and Human Services Food and Drug Administration, Silver Spring, Md, USA, 2012.
  9. US Department of Health and Human Services and Food and Drug Administration, Guidance for Industry (Draft): Clinical Pharmacology Data to Support a Demonstration of Biosimilarity to a Reference Product, 2012, http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM397017.pdf.
  10. L. F. Flores-Ortiz, V. R. Campos-García, F. C. Perdomo-Abúndez, N. O. Pérez, and E. Medina-Rivero, “Physicochemical properties of Rituximab,” Journal of Liquid Chromatography and Related Technologies, vol. 37, no. 10, pp. 1438–1452, 2014. View at Publisher · View at Google Scholar · View at Scopus
  11. V. Pérez Medina-Martínez, M. E. Abad-Javier, A. J. Romero-Díaz et al., “Comparability of a three-dimensional structure in biopharmaceuticals using spectroscopic methods,” Journal of Analytical Methods in Chemistry, vol. 2014, Article ID 950598, 11 pages, 2014. View at Publisher · View at Google Scholar · View at Scopus
  12. C. E. Espinosa- de la Garza, F. C. Perdomo-Abúndez, J. Padilla-Calderón et al., “Analysis of recombinant monoclonal antibodies by capillary zone electrophoresis,” Electrophoresis, vol. 34, no. 8, pp. 1133–1140, 2013. View at Publisher · View at Google Scholar · View at Scopus
  13. M. P. Miranda-Hernández, C. A. López-Morales, N. D. Ramírez-Ibáñez et al., “Assessment of physicochemical properties of rituximab related to its immunomodulatory activity,” Journal of Immunology Research, vol. 2015, Article ID 910763, 10 pages, 2015. View at Publisher · View at Google Scholar · View at Scopus
  14. V. Kayser, N. Chennamsetty, V. Voynov, B. Helk, and B. L. Trout, “Tryptophan-tryptophan energy transfer and classification of tryptophan residues in proteins using a therapeutic monoclonal antibody as a model,” Journal of Fluorescence, vol. 21, no. 1, pp. 275–288, 2011. View at Publisher · View at Google Scholar · View at Scopus
  15. P. R. Callis, “1La and 1Lb transitions of tryptophan: applications of theory and experimental observations to fluorescence of proteins,” in Methods in Enzymology, vol. 278, pp. 113–150, 1997. View at Google Scholar
  16. R. W. Cowgill, “Fluorescence and the structure of proteins II. Fluorescence of peptides containing tryptophan or tyrosine,” Biochimica et Biophysica Acta, vol. 75, pp. 272–273, 1963. View at Publisher · View at Google Scholar · View at Scopus
  17. R. W. Cowgill, “Fluorescence and the structure of proteins. I. Effects of substituents on the fluorescence of indole and phenol compounds,” Archives of Biochemistry and Biophysics, vol. 100, no. 1, pp. 36–44, 1963. View at Publisher · View at Google Scholar · View at Scopus
  18. H. Liu, G. Caza-Bulseco, D. Faldu, C. Chumsae, and J. Sun, “Heterogeneity of monoclonal antibodies,” Journal of Pharmaceutical Sciences, vol. 97, no. 7, pp. 2426–2447, 2008. View at Publisher · View at Google Scholar · View at Scopus
  19. M. Schiestl, T. Stangler, C. Torella, T. Čepeljnik, H. Toll, and R. Grau, “Acceptable changes in quality attributes of glycosylated biopharmaceuticals,” Nature Biotechnology, vol. 29, no. 4, pp. 310–312, 2011. View at Publisher · View at Google Scholar · View at Scopus
  20. W. S. Putnam, S. Prabhu, Y. Zheng, M. Subramanyam, and Y.-M. C. Wang, “Pharmacokinetic, pharmacodynamic and immunogenicity comparability assessment strategies for monoclonal antibodies,” Trends in Biotechnology, vol. 28, no. 10, pp. 509–516, 2010. View at Publisher · View at Google Scholar · View at Scopus
  21. L. A. Khawli, S. Goswami, R. Hutchinson et al., “Charge variants in IgG1. Isolation, characterization, in vitro binding properties and pharmacokinetics in rats,” mAbs, vol. 2, no. 6, pp. 613–624, 2010. View at Publisher · View at Google Scholar · View at Scopus
  22. H. Li and M. d'Anjou, “Pharmacological significance of glycosylation in therapeutic proteins,” Current Opinion in Biotechnology, vol. 20, no. 6, pp. 678–684, 2009. View at Publisher · View at Google Scholar · View at Scopus
  23. J. Davies, L. Jiang, L.-Z. Pan, M. J. Labarre, D. Anderson, and M. Reff, “Expression of GnTIII in a recombinant anti-CD20 CHO production cell line: expression of antibodies with altered glycoforms leads to an increase in ADCC through higher affinity for FcγRIII,” Biotechnology and Bioengineering, vol. 74, no. 4, pp. 288–294, 2001. View at Publisher · View at Google Scholar · View at Scopus
  24. R. L. Shields, J. Lai, R. Keck et al., “Lack of fucose on human IgG1 N-linked oligosaccharide improves binding to human FcγRIII and antibody-dependent cellular toxicity,” The Journal of Biological Chemistry, vol. 277, no. 30, pp. 26733–26740, 2002. View at Publisher · View at Google Scholar · View at Scopus
  25. T. Igawa, H. Tsunoda, T. Tachibana et al., “Reduced elimination of IgG antibodies by engineering the variable region,” Protein Engineering, Design & Selection, vol. 23, no. 5, pp. 385–392, 2010. View at Publisher · View at Google Scholar · View at Scopus
  26. Y. Y. Sham, I. Muegge, and A. Warshel, “The effect of protein relaxation on charge-charge interactions and dielectric constants of proteins,” Biophysical Journal, vol. 74, no. 4, pp. 1744–1753, 1998. View at Publisher · View at Google Scholar · View at Scopus
  27. G. Wells, J.-C. Becker, J. Teng et al., “Validation of the 28-joint Disease Activity Score (DAS28) and European League Against Rheumatism response criteria based on C-reactive protein against disease progression in patients with rheumatoid arthritis, and comparison with the DAS28 based on erythrocyte sedimentation rate,” Annals of the Rheumatic Diseases, vol. 68, no. 6, pp. 954–960, 2009. View at Publisher · View at Google Scholar · View at Scopus
  28. D. T. La, C. E. Collins, H.-T. Yang, T.-S. Migone, and W. Stohl, “B lymphocyte stimulator expression in patients with rheumatoid arthritis treated with tumour necrosis factor α antagonists: differential effects between good and poor clinical responders,” Annals of the Rheumatic Diseases, vol. 67, no. 8, pp. 1132–1138, 2008. View at Publisher · View at Google Scholar · View at Scopus
  29. A. Kavanaugh, L. Klareskog, D. Van der Heijde, J. Li, B. Freundlich, and M. Hooper, “Improvements in clinical response between 12 and 24 weeks in patients with rheumatoid arthritis on Etanercept therapy with or without methotrexate,” Annals of the Rheumatic Diseases, vol. 67, no. 10, pp. 1444–1447, 2008. View at Publisher · View at Google Scholar · View at Scopus