Abstract
Antibody formation is an intended physiological reaction to a “non-self” protein intentionally triggered in the case of vaccines. However, an unwanted immune response to a therapeutic protein may lead to a loss of efficacy and/or to severe side effects. The Committee for Medicinal Products for Human Use (CHMP) at the European Medicines Agency (EMA) issued a multidisciplinary guideline providing general recommendations from a marketing authorisation perspective on how to systematically assess an unwanted immune response following the administration of a biological drug. In this article, we discuss key aspects of this guideline and its concept, with a particular focus on the impact of immunogenicity on benefit/risk estimation of a therapeutic protein.
Keywords: Immunogenicity, biotechnology derived proteins, benefit/risk, risk assessment, regulatory guideline
Current Drug Safety
Title: Immunogenicity and its Impact on Benefit/Risk Considerations in the Authorisation of Biopharmaceuticals
Volume: 5 Issue: 4
Author(s): Isabel C. Buttel, Katrin Voller and Christian K. Schneider
Affiliation:
Keywords: Immunogenicity, biotechnology derived proteins, benefit/risk, risk assessment, regulatory guideline
Abstract: Antibody formation is an intended physiological reaction to a “non-self” protein intentionally triggered in the case of vaccines. However, an unwanted immune response to a therapeutic protein may lead to a loss of efficacy and/or to severe side effects. The Committee for Medicinal Products for Human Use (CHMP) at the European Medicines Agency (EMA) issued a multidisciplinary guideline providing general recommendations from a marketing authorisation perspective on how to systematically assess an unwanted immune response following the administration of a biological drug. In this article, we discuss key aspects of this guideline and its concept, with a particular focus on the impact of immunogenicity on benefit/risk estimation of a therapeutic protein.
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Cite this article as:
Buttel C. Isabel, Voller Katrin and Schneider K. Christian, Immunogenicity and its Impact on Benefit/Risk Considerations in the Authorisation of Biopharmaceuticals, Current Drug Safety 2010; 5 (4) . https://dx.doi.org/10.2174/157488610792245993
DOI https://dx.doi.org/10.2174/157488610792245993 |
Print ISSN 1574-8863 |
Publisher Name Bentham Science Publisher |
Online ISSN 2212-3911 |
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