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Nephrology Dialysis Transplantation 2006 21(Supplement 5):v9-v12; doi:10.1093/ndt/gfl476
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© The Author [2006]. Published by Oxford University Press on behalf of ERA-EDTA. All rights reserved. For Permissions, please email: journals.permissions@oxfordjournals.org

Immunogenicity of biopharmaceuticals

Michele Kessler1,, David Goldsmith2 and Huub Schellekens3

1Department of Nephrology-Dialysis-Transplantation, University Hospital of Nancy, France, 2Renal Medicine and Transplantation Department, Guy's Hospital, London, UK and 3Department of Innovation Studies, Utrecht University, Utrecht, The Netherlands

Correspondence and offprint requests to: Dr Michele Kessler, Service de Néphrologie, Hôpitaux de Brabois, CHU de Nancy, 54500 Vandoeuvre les Nancy, France. Email: m.kessler{at}chu-nancy.fr

The availability of biopharmaceuticals has been increasing over the past decade and as their patents expire, the emergence of biosimilar agents approaches. The primary issue of concern for the safety of these agents is the potential for immunogenicity. Both product- and host-related factors have documented impact on the immune response, but many factors are still unknown. Although in many cases the presence of antibodies may have little clinical consequence, the upsurge of pure red cell aplasia cases further increased concerns about potential clinical consequences of extensive use of biopharmaceuticals and biosimilars. Available laboratory measurement methods are insufficient to predict biological and clinical properties of biopharmaceuticals, or even to compare their bioequivalence. Comparison of results from different studies is complicated by the variability of assay measurements, presentation of data and lack of standardization.

Keywords: antigen; biopharmaceuticals; biosimilars; erythropoietin; immunogenicity; PRCA; risk factors


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