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Current Drug Safety


ISSN (Print): 1574-8863
ISSN (Online): 2212-3911

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

Author(s): Isabel C. Buttel, Katrin Voller and Christian K. Schneider

Volume 5 , Issue 4 , 2010

Page: [287 - 292] Pages: 6

DOI: 10.2174/157488610792245993

Price: $65


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

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