Immunogenicity and its Impact on Benefit/Risk Considerations in the Authorisation of Biopharmaceuticals

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.

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