title: Immunogenicity of biopharmaceuticals. The European perspective.
abstract: In 1993 a Concerted EU Action was started to coordinate research concerning the immunogenicity of biopharmaceuticals bringing together researchers from academia and industry. The main topic of this concerted action has been interferon alpha. The factors influencing its immunogenicity were studied. Blind panel testing of patients' sera showed large differences in reported titres as an important variable in different studies. The EMEA has requested the three marketing authorization holders of interferon beta to develop a common assay for antibodies to this product. The status of this project will be discussed. The occurrence of about 30 cases of pure red cell aplasia related to antibodies induced by erythropoietin treatment will also be reported.
authors.affiliation: Central Laboratory Animal Institute, Department of Innovation Studies, University of Utrecht, Utrecht, The Netherlands. h.schellekens@gdl.uu.nl
authors.forename: H
authors.initials: H
authors.lastname: Schellekens
authors.forename: N
authors.initials: N
authors.lastname: Casadevall
mesh_terms: D001685:Biological Factors / Q000276:immunology*; D001702:Biopharmaceutics; D004921:Erythropoietin / Q000276:immunology; D005062:European Union; D006801:Humans; D016899:Interferon-beta / Q000276:immunology; D040541:Marketing; D011994:Recombinant Proteins; D012010:Red-Cell Aplasia, Pure / Q000209:etiology / Q000276:immunology
chemical_list: D001685:Biological Factors; D011994:Recombinant Proteins; D004921:Erythropoietin; D016899:Interferon-beta