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Immunogenicity and its impact on benefit/risk considerations in the authorisation of biopharmaceuticals

Isabel C Büttel1, Katrin Völler, Christian K Schneider

  • 1Paul-Ehrlich-Institut, Federal Institute for Vaccines and Biomedicines, Langen, Germany. bueis@pei.de

Current Drug Safety
|July 10, 2010
PubMed

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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