Publisher： Bentham Science Publishers
E-ISSN： 2212-3911|5|4|287-292
ISSN： 1574-8863
Source： Current Drug Safety, Vol.5, Iss.4, 2010-10, pp. : 287-292
Disclaimer: Any content in publications that violate the sovereignty, the constitution or regulations of the PRC is not accepted or approved by CNPIEC.
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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