메뉴 건너뛰기




Volumn 7, Issue 3, 2015, Pages 373-381

Comparative immunogenicity assessment: A critical consideration for biosimilar development

Author keywords

[No Author keywords available]

Indexed keywords

BIOSIMILAR AGENT; DRUG ANTIBODY; EPITOPE; REAGENT;

EID: 84923354566     PISSN: 17576180     EISSN: 17576199     Source Type: Journal    
DOI: 10.4155/bio.14.311     Document Type: Review
Times cited : (25)

References (23)
  • 1
    • 33644952525 scopus 로고    scopus 로고
    • European Medicines Agency. Committee for Medicinal Products for Human Use (CHMP)
    • European Medicines Agency. Committee for Medicinal Products for Human Use (CHMP). Guideline on similar biological medicinal products. www.ema.europa.eu/docs/en-GB/document-library/Scientific-guideline/2009/09/WC500003517.pdf.
    • Guideline on Similar Biological Medicinal Products.
  • 11
    • 60549104490 scopus 로고    scopus 로고
    • European Medicines Agency. Committee for Medicinal Products for Human Use (CHMP)
    • European Medicines Agency. Committee for Medicinal Products for Human Use (CHMP). Guideline on immunogenicity assessment of biotechnology-derived therapeutic proteins. www.ema.europa.eu/docs/en-GB/document-library/Scientific-guideline/2009/09/WC500003946.pdf.
    • Guideline on Immunogenicity Assessment of Biotechnology-derived Therapeutic Proteins.
  • 13
    • 58249116651 scopus 로고    scopus 로고
    • Recommendations for the validation of immunoassays used for detection of host antibodies against biotechnology products
    • Shankar G, Devanarayan V, Amaravadi L et al. Recommendations for the validation of immunoassays used for detection of host antibodies against biotechnology products. J. Pharm. Biomed. Anal. 48, 1267-1281 (2008).
    • (2008) J. Pharm. Biomed. Anal. , vol.48 , pp. 1267-1281
    • Shankar, G.1    Devanarayan, V.2    Amaravadi, L.3
  • 14
    • 79953096763 scopus 로고    scopus 로고
    • Recommendations and requirements for the design of bioanalytical testing used in comparability studies for biosimilar drug development
    • 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).
    • (2011) Bioanalysis , vol.3 , Issue.5 , pp. 535-540
    • Cai, X.Y.1    Gouty, D.2    Baughman, S.3
  • 15
    • 84866933842 scopus 로고    scopus 로고
    • Challenges of developing and validating immunogenicity assays to support comparability studies for biosimilar drug development
    • 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).
    • (2012) Bioanalysis , vol.4 , Issue.17 , pp. 2169-2177
    • Cai, X.Y.1    Thomas, J.2    Cullen, C.3
  • 16
    • 84923358069 scopus 로고    scopus 로고
    • European Bioanalysis Forum
    • European Bioanalysis Forum. Outcome of EBF Survey on Biosimilars. http://bcn2012.europeanbioanalysisforum.eu/slides/ day%202/ii%20biosimilars/2-munday.pdf.
    • Outcome of EBF Survey on Biosimilars.
  • 18
    • 40849142102 scopus 로고    scopus 로고
    • Cetuximab-induced anaphylaxis and IgE specific for galactose-A-1, 3-Galactose
    • Christine HC, Mirakhur B, Chan E et al. Cetuximab-induced anaphylaxis and IgE specific for galactose-A-1, 3-Galactose. N. Engl. J. Med. 358(11), 1109-1117 (2008).
    • (2008) N. Engl. J. Med. , vol.358 , Issue.11 , pp. 1109-1117
    • Christine, H.C.1    Mirakhur, B.2    Chan, E.3
  • 19
    • 79953681018 scopus 로고    scopus 로고
    • Immunogenicity of biotherapeutics in the context of developing biosimilars and biobetters
    • Barbosa MDFS. Immunogenicity of biotherapeutics in the context of developing biosimilars and biobetters. Drug Discov. Today 16(7-8), 345-353 (2011).
    • (2011) Drug Discov. Today , vol.16 , Issue.7-8 , pp. 345-353
    • Barbosa, M.D.F.S.1
  • 20
    • 48349093740 scopus 로고    scopus 로고
    • HLA-DRB1 0401 and HLA-DRB1 0408 are strongly associated with the development of antibodies against interferon-b therapy in multiple sclerosis
    • 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).
    • (2008) Am. J. Hum. Genet. , vol.83 , pp. 219-227
    • Hoffmann, S.1    Cepok, S.2    Grummel, V.3
  • 21
    • 77958509120 scopus 로고    scopus 로고
    • A novel homogeneous biotin-digoxigenin based assay for the detection of human anti-Therapeutic antibodies in autoimmune serum
    • 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).
    • (2010) J. Immunol. Methods , vol.362 , pp. 101-111
    • Qiu, Z.J.1    Ying, Y.2    Fox, M.3
  • 22
    • 79956124888 scopus 로고    scopus 로고
    • A formal comparison of different methods for establishing cut points to distinguish positive and negative samples in immunoassays
    • 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).
    • (2011) J. Pharm. Biomed. Anal. , vol.55 , Issue.5 , pp. 1148-1156
    • Jaki, T.1    Lawo, J.P.2    Wolfsegger, M.J.3
  • 23
    • 84903597970 scopus 로고    scopus 로고
    • Assessment and reporting of the clinical immunogenicity of therapeutic proteins and peptides-Harmonized terminology and tactical recommendations
    • 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).
    • (2014) AAPS J. , vol.16 , Issue.4 , pp. 658-673
    • Shankar, G.1    Arkin, S.2    Cocea, L.3


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.