title: Immunogenicity and its impact on benefit/risk considerations in the authorisation of biopharmaceuticals.
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.
authors.affiliation: Paul-Ehrlich-Institut, Federal Institute for Vaccines and Biomedicines, Langen, Germany. bueis@pei.de
authors.forename: Isabel  C
authors.initials: I
authors.lastname: Büttel
authors.forename: Katrin
authors.initials: K
authors.lastname: Völler
authors.forename: Christian  K
authors.initials: C
authors.lastname: Schneider
mesh_terms: D000917:Antibody Formation; D001688:Biological Products / Q000009:adverse effects* / Q000276:immunology*; D017277:Drug Approval / Q000458:organization & administration*; D004345:Drug Industry / Q000458:organization & administration; D064420:Drug-Related Side Effects and Adverse Reactions; D006801:Humans; D007880:Legislation, Drug; D040541:Marketing; D018570:Risk Assessment
chemical_list: D001688:Biological Products