Biopharmaceuticals (BPs) represent a rapidly growing class of approved and investigational drug therapies that is contributing significantly to advancing treatment in multiple disease areas, including inflammatory and autoimmune diseases, genetic deficiencies and cancer. Unfortunately, unwanted immunogenic responses to BPs, in particular those affecting clinical safety or efficacy, remain among the most common negative effects associated with this important class of drugs. To manage and reduce risk of unwanted immunogenicity, diverse communities of clinicians, pharmaceutical industry and academic scientists are involved in: interpretation and management of clinical and biological outcomes of BP immunogenicity, improvement of methods for describing, predicting and mitigating immunogenicity risk and elucidation of underlying causes. Collaboration and alignment of efforts across these communities is made difficult due to lack of agreement on concepts, practices and standardized terms and definitions related to immunogenicity. The Innovative Medicines Initiative (IMI; www.imi-europe.org), ABIRISK consortium [Anti-Biopharmaceutical (BP) Immunization Prediction and Clinical Relevance to Reduce the Risk; www.abirisk.eu] was formed by leading clinicians, academic scientists and EFPIA (European Federation of Pharmaceutical Industries and Associations) members to elucidate underlying causes, improve methods for immunogenicity prediction and mitigation and establish common definitions around terms and concepts related to immunogenicity. These efforts are expected to facilitate broader collaborations and lead to new guidelines for managing immunogenicity. To support alignment, an overview of concepts behind the set of key terms and definitions adopted to date by ABIRISK is provided herein along with a link to access and download the ABIRISK terms and definitions and provide comments (http://www.abirisk.eu/index_t_and_d.asp).

CEA Saclay Institute of Biology and Technologies Gif sur Yvette France

Centre for Neuroscience and Trauma Blizard Institute Queen Mary University of London London UK

Centre for Rheumatology Research University College London London UK

Centre for Rheumatology University College London London UK

Clinical Immunology and Rheumatology University of Amsterdam Amsterdam the Netherlands

CNRS UMR 7292 'GICC' Faculty of Medicine Tours France

Department of Clinical Neuroscience Karolinska Institutet Stockholm Sweden

Department of Neurology and Center for Clinical Neuroscience MS Center Charles University Prague Prague Czech Republic

Department of Neurology Innsbruck Medical University Innsbruck Austria

Department of Neurology University of Copenhagen Copenhagen Denmark

Dipartimento di Medicina Sperimentale e Clinica Universita di Firenze Firenze Italy

Division of Haematology Transfusion Medicine Paul Ehrlich Institut Langen Germany

Drug Metabolism Pharmacokinetics Biologics Novartis Institutes for Biomedical Research Basel Switzerland

GlaxoSmithKline Clinical Immunology Biopharm King of Prussia PA USA

GlaxoSmithKline Clinical Immunology Biopharm R and D King of Prussia PA USA

GlaxoSmithKline Worldwide Epidemiology Southall UK

Hôpital Saint Louis Department of Gastroenterology GETAID Paris France

INSERM U1012 Hôpitaux Universitaires Paris Sud Rhumatologie Paris France

INSERM UMR S 1138 Université Pierre et Marie Curie Paris France

INSERM UMR669 University of Paris Sud France

INSERM UMR996 Faculté Pharmacie Université Paris Sud France

Institute of Experimental Haematology and Transfusion Medicine University Clinic Bonn Bonn Germany

Ipsen Innovation Pharmacokinetics Drug Metabolism Department Les Ulis France

Istituto Giannina Gaslini Pediatria 2 Rheumatology Genova Italy

Merck Serono Institute of Drug Metabolism and Pharmacokinetics Grafing Germany

Novo Nordisk Immunogenicity Måløv Denmark

Pfizer Drug Safety R and D Groton CT USA

Pfizer Early Biotech Clinical Development Cambridge MA USA

Pfizer Immunogenicity Sciences Disciple Pharmacokinetics Dynamics and Metabolism

Sanofi Aventis Clinical Exploratory and Pharmacology Chilly Mazerin FR

Sanofi Aventis Structural Biology Paris France

UCB Pharma Bioanalytical R and D Slough UK

University of Tours Francois Rabelais CNRS UMR 7292 Tours France

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