Target-directed development and preclinical characterization of the proposed biosimilar rituximab GP2013

References

• Brekke OH, Sandlie I. Therapeutic antibodies for human diseases at the dawn of the twenty-first century. Nat Rev Drug Discov 2003;2: 52–62.
   PubMed Web of Science ®Google Scholar
• Reichert JM. Trends in US approvals: new biopharmaceuticals and vaccines. Trends Biotechnol 2006;24:293–298.
   PubMed Web of Science ®Google Scholar
• Cornes P. The economic pressures for biosimilar drug use in cancer medicine. Target Oncol 2012;7(Suppl. 1):S57–S67.
   PubMed Web of Science ®Google Scholar
• McCamish M, Woollett G. Worldwide experience with biosimilar development. MAbs 2011;3:209–217.
   PubMed Web of Science ®Google Scholar
• McCamish M, Woollett G. The state of the art in the development of biosimilars. Clin Pharmacol Ther 2012;91:405–417.
   PubMed Web of Science ®Google Scholar
• European Medicines Agency, Committee for Medicinal Products for Human Use (CHMP). Guideline on similar biological medicinal products containing monoclonal antibodies – non-clinical and clinical issues. London: European Medicines Agency; 2012. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2012/06/WC500128686.pdf
   Google Scholar
• Food and Drug Administration, Center for Drug Evaluation and Research (CDER). Guidance for Industry. Scientific considerations in demonstrating biosimilarity to a reference product. Rockville, MD, Food and Drug Administration; 2012. Available from: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM291128.pdf
   Google Scholar
• Schiestl M, Stangler T, Torella C, et al. Acceptable changes in quality attributes of glycosylated biopharmaceuticals. Nat Biotechnol 2011;29:310–312.
   PubMed Web of Science ®Google Scholar
• Berkowitz SA, Engen JR, Mazzeo JR, et al. Analytical tools for characterizing biopharmaceuticals and the implications for biosimilars. Nat Rev Drug Discov 2012;11:527–540.
   PubMed Web of Science ®Google Scholar
• Beck A, Diemer H, Ayoub D, et al. Analytical characterization of biosimilar antibodies and Fc-fusion proteins. Trends Anal Chem 2013;48:81–95.
   Web of Science ®Google Scholar
• Cartron G, Dacheux L, Salles G, et al. Therapeutic activity of humanized anti-CD20 monoclonal antibody and polymorphism in IgG Fc receptor FcgammaRIIIa gene. Blood 2002;99:754–758.
   PubMed Web of Science ®Google Scholar
• van Meerten T, van Rijn RS, Hol S, et al. Complement-induced cell death by rituximab depends on CD20 expression level and acts complementary to antibody-dependent cellular cytotoxicity. Clin Cancer Res 2006;12:4027–4035.
   PubMed Web of Science ®Google Scholar
• Weiner GJ. Rituximab: mechanism of action. Semin Hematol 2010;47:115–123.
   PubMed Web of Science ®Google Scholar
• Maloney DG, Smith B, Rose A. Rituximab: mechanism of action and resistance. Semin Oncol 2002;29(Suppl. 2):2–9.
   PubMed Web of Science ®Google Scholar
• Vital EM, Kay J, Emery P. Rituximab biosimilars. Expert Opin Biol Ther 2013;13:1049–1062.
   PubMed Web of Science ®Google Scholar
• Dorvignit D, Palacios JL, Merino M, et al. Expression and biological characterization of an anti-CD20 biosimilar candidate antibody. A case study. mAbs 2012;4:488–496.
   PubMed Web of Science ®Google Scholar
• Visser J, Feuerstein I, Stangler T, et al. Physicochemical and functional comparability between the proposed biosimilar rituximab GP2013 and originator rituximab. BioDrugs2013;27:495–507.
   Google Scholar
• Jiang X-R, Song A, Bergelson S, et al. Advances in the assessment and control of the effector functions of therapeutic antibodies. Nat Rev Drug Discov 2011;10:101–111.
   PubMed Web of Science ®Google Scholar
• Beck A, Sanglier-Cianferani S, Van Dorsselaer A. Biosimilar, biobetter, and next generation antibody characterization by mass spectroscopy. Anal Chem 2012;84:4637–4646.
   PubMed Web of Science ®Google Scholar
• Vugmeyster Y, Howell K, Bakshl A, et al. Effect of anti-CD20 monoclonal antibody, Rituxan, on cynomolgus monkey and human B cells in a whole blood matrix. Cytometry 2003;52:101–109.
   PubMedGoogle Scholar
• Tao MH, Morrison SL. Studies of aglycosylated chimeric mouse-human IgG. Role of carbohydrate in the structure and effector functions mediated by the human IgG constant region. J Immunol 1989;143:2595–2601.
   PubMed Web of Science ®Google Scholar
• Kubota T, Niwa R, Satoh M, et al. Engineered therapeutic antibodies with improved effector functions. Cancer Sci 2009;100: 1566–1572.
   PubMed Web of Science ®Google Scholar
• Li C, Rossomando A, Wu S-L, et al. Comparability analysis of anti-CD20 commercial (rituximab) and RNAi-mediated fucosylated antibodies by two LC-MS approaches. mAbs 2013;5:565–575.
   PubMed Web of Science ®Google Scholar
• Shields RL, Lai J, Keck R, et al. Lack of fucose on human IgG1 N-linked oligosaccharide improves binding to human Fcgamma RIII and antibody-dependent cellular toxicity. J Biol Chem 2002;277: 26733–26740.
   PubMed Web of Science ®Google Scholar
• de Romeuf C, Dutertre CA, Le Garff-Tavernier M, et al. Chronic lymphocytic leukaemia cells are efficiently killed by an anti-CD20 monoclonal antibody selected for improved engagement of FcgammaRIIIA/CD16. Br J Haematol 2008;140: 635–643.
   PubMed Web of Science ®Google Scholar
• Chung S, Quarmby V, Gao X, et al. Quantitative evaluation of fucose reducing effects in a humanized antibody on Fcγ receptor binding and antibody-dependent cell-mediated cytotoxicity activities. mAbs 2012;4:326–340.
   PubMed Web of Science ®Google Scholar
• Ternant D, Paintaud G. Pharmacokinetics and concentration-effect relationships of therapeutic monoclonal antibodies and fusion proteins. Expert Opin Biol Ther 2005;5(Suppl. 1):S37–S47.
   PubMed Web of Science ®Google Scholar
• Wang W, Lu P, Fang Y, et al. Monoclonal antibodies with identical Fc sequences can bind to FcRn differentially with pharmacokinetic consequences. Drug Metab Dispos 2011;39:1469–1477.
   PubMed Web of Science ®Google Scholar
• Keizer RJ, Huitema AD, Schellens JH, et al. Clinical pharmacokinetics of therapeutic monoclonal antibodies. Clin Pharmacokinet 2010;49:493–507.
   PubMed Web of Science ®Google Scholar