title: Immunogenicity of biotherapeutics in the context of developing biosimilars and biobetters.
abstract: Issues concerning the approval of biosimilars are currently being addressed by the US Food and Drug Administration and the European Medicines Agency. There appears to be a consensus that immunogenicity impacts comparability studies and the interchangeability of biosimilars. In addition, preclinical immunogenicity assessment and mitigation, if validated in clinical studies, might impact patient safety and development costs, and also facilitate the development of 'biobetters' and other protein therapeutics. This review addresses recent advances in the field of biosimilars and focuses on predictive immunology, with an emphasis on preclinical immunogenicity assessments of protein therapeutics other than vaccines and their corresponding clinical outcomes.
authors.affiliation: CA Consultants, PO Box 2390, Iowa City, IA 52244, USA. mbarbosa@cacobio.com
authors.forename: Maria D F S
authors.initials: MD
authors.lastname: Barbosa
mesh_terms: D000818:Animals; D000917:Antibody Formation; D001688:Biological Products / Q000276:immunology* / Q000378:metabolism / Q000493:pharmacokinetics*; D015195:Drug Design; D006801:Humans; D051379:Mice; D013810:Therapeutic Equivalency; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D001688:Biological Products