title: Immunogenicity assessment of biotherapeutic products: An overview of assays and their utility.
abstract: Biotherapeutic products (BTPs) are the fastest growing medicines in the pharmaceutical market. Despite their clinical success, the immunogenicity of BTPs continues to be a major concern. Assessment of immunogenicity as well as appropriate interpretation of immunogenicity data is therefore, of critical importance for defining safety profile of these products for the purpose of their licensure and use. In the past decade, much progress has been made towards how immunogenicity should be studied. This article reflects the content of the brief presentation on principles of methods used for immunogenicity assessment and their merits and limitations given at the first World Health Organization (WHO) implementation workshop on rDNA derived biotherapeutic products held in the Republic of Korea in May 2014 to support the case studies on immunogenicity presented and discussed during the workshop. The purpose of this article is to provide an overview of the methods used for assessing immunogenicity of biotherapeutic products (BTPs) and the most important considerations in interpreting results in the context of regulatory overview of these products.
authors.affiliation: National Institute for Biological Standards and Control (NIBSC), Biotherapeutics Group, Blanche Lane, South Mimms, Potters Bar, Hertfordshire EN6 3QG, United Kingdom. Electronic address: Meenu.Wadhwa@nibsc.org.
authors.forename: Meenu
authors.initials: M
authors.lastname: Wadhwa
authors.affiliation: World Health Organization, Department of Essential Medicines and Health Products, Avenue Appia 20, CH-1211 Geneva, Switzerland.
authors.forename: Ivana
authors.initials: I
authors.lastname: Knezevic
authors.affiliation: World Health Organization, Department of Essential Medicines and Health Products, Avenue Appia 20, CH-1211 Geneva, Switzerland.
authors.forename: Hye-Na
authors.initials: HN
authors.lastname: Kang
authors.affiliation: 8 Old Forge Close, Welwyn AL6 0SR, United Kingdom.
authors.forename: Robin
authors.initials: R
authors.lastname: Thorpe
mesh_terms: D000906:Antibodies / Q000032:analysis / Q000276:immunology; D001688:Biological Products / Q000276:immunology*; D004345:Drug Industry; D009500:Neutralization Tests
chemical_list: D000906:Antibodies; D001688:Biological Products
keywords: Assays; Biosimilars; Biotherapeutic products; Immunogenicity assessment; Regulatory evaluation; WHO guidelines