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Comparative immunogenicity assessment Review


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12 US Food and Drug Administration. Guidance for industry – assay development for immunogenicity testing of therapeutic proteins (Draft guidance). www.fda.gov/downloads/Drugs/ Guidances/UCM192750.pdf.


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14 Cai XY, Gouty D, Baughman S et al. Recommendations and requirements for the design of bioanalytical testing used in comparability studies for biosimilar drug development. Bioanalysis 3(5), 535–540 (2011).


15 Cai XY, Thomas J, Cullen C et al. Challenges of developing and validating immunogenicity assays to support comparability studies for biosimilar drug development. Bioanalysis 4(17), 2169–2177 (2012).


16 European Bioanalysis Forum. Outcome of EBF Survey on Biosimilars. http://bcn2012.europeanbioanalysisforum.eu/slides/ day%202/ii%20biosimilars/2_munday.pdf.


17 US Food and Drug Administration. Guidance for industry – immunogenicity assessment for therapeutic proteins (Draft guidance). www.fda.gov/downloads/drugs/ guidancecomplianceregulatoryinformation/guidances/ ucm338856.pdf.


18 Christine HC, Mirakhur B, Chan E et al. Cetuximab- induced anaphylaxis and IgE specific for galactose-α-1,3- Galactose. N. Engl. J. Med. 358(11), 1109–1117 (2008).


19 Barbosa MDFS. Immunogenicity of biotherapeutics in the context of developing biosimilars and biobetters. Drug Discov. Today 16(7-8), 345–353 (2011).


20 Hoffmann S, Cepok S, Grummel V et al. HLA-DRB1*0401 and HLA-DRB1*0408 are strongly associated with the development of antibodies against interferon-b therapy in multiple sclerosis. Am. J. Hum. Genet. 83, 219–227 (2008).


21 Qiu ZJ, Ying Y, Fox M et al. A novel homogeneous biotin– digoxigenin based assay for the detection of human anti- therapeutic antibodies in autoimmune serum. J. Immunol. Methods 362, 101–111 (2010).


22 Jaki T, Lawo JP, Wolfsegger MJ et al. A formal comparison of different methods for establishing cut points to distinguish positive and negative samples in immunoassays. J. Pharm. Biomed. Anal. 55(5), 1148–1156 (2011).


23 Shankar G, Arkin S, Cocea L et al. Assessment and reporting of the clinical immunogenicity of therapeutic proteins and peptides – harmonized terminology and tactical recommendations. AAPS J. 16(4), 658–673 (2014).


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