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Open Access 01-06-2016 | Review Article

Assessing the Immunogenicity of Biopharmaceuticals

Authors: Carlos Pineda, Gilberto Castañeda Hernández, Ira A. Jacobs, Daniel F. Alvarez, Claudio Carini

Published in: BioDrugs | Issue 3/2016

Abstract

Biopharmaceuticals have the potential to raise an immunogenic response in treated individuals, which may impact the efficacy and safety profile of these drugs. As a result, it is essential to evaluate immunogenicity throughout the different phases of the clinical development of a biopharmaceutical, including post-marketing surveillance. Although rigorous evaluation of biopharmaceutical immunogenicity is required by regulatory authorities, there is a lack of uniform standards for the type, quantity, and quality of evidence, and for guidance on experimental design for immunogenicity assays or criteria to compare immunogenicity of biopharmaceuticals. Moreover, substantial technological advances in methods to assess immune responses have yielded higher immunogenicity rates with modern assays, and limit comparison of immunogenicity of biopharmaceuticals outside of head-to-head clinical trials. Accordingly, research programs, regulatory agencies, and clinicians need to keep pace with continuously evolving analyses of immunogenicity. Here, we review factors associated with immunogenicity of biopharmaceuticals, potential clinical ramifications, and current regulatory guidance for evaluating immunogenicity, and discuss methods to assess immunogenicity in non-clinical and clinical studies. We also describe special considerations for evaluating the immunogenicity of biosimilar candidates.

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Title: Assessing the Immunogenicity of Biopharmaceuticals
Authors: Carlos Pineda
Gilberto Castañeda Hernández
Ira A. Jacobs
Daniel F. Alvarez
Claudio Carini
Publication date: 01-06-2016
Publisher: Springer International Publishing
Published in: BioDrugs / Issue 3/2016
Print ISSN: 1173-8804
Electronic ISSN: 1179-190X
DOI: https://doi.org/10.1007/s40259-016-0174-5

At a glance: The STEP trials

Springer Medicine

Assessing the Immunogenicity of Biopharmaceuticals

Abstract

At a glance: The STEP trials

Springer Medicine

Abstract

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