Department of Clinical Immunogenicity Analysis, Novo Nordisk A/S, Maaloev, Denmark
Joao A. Pedras-Vasconcelos
Division of Biotech Review and Research III, Office of Biotechnology Products, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA
Laura. I. Salazar-Fontana
LAIZ Regulatory Science, Lausanne, Switzerland
Sebastian Spindeldreher
Integrated Biologix GmbH, Basel, Switzerland
Zuben Sauna
Division of hemostasis, Office of Plasma Protein Therapeutics; Office of Therapeutic Products, Center for Biologics Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA
Veerle Snoeck
Translational Biomarkers and Bioanalysis, UCB Biopharma SRL, Braine-l’Alleud, Belgium
Daniela Verthelyi
Division of Biologics Research and Review III; Ofrfice of Biotechnology Products; Center for Drug Evaluation and Research; Office of Pharmaceutical Quality, US Food and Drug Administration, Silver Spring, MD, USA
Daniel Kramer
Global Scientific Advisor Immunogenicity, Translational Medicine & Early Development, Sanofi Aventis Deutschland GmbH, Frankfurt am Main, Germany
Biologics have revolutionized disease management in many therapeutic areas by addressing unmet medical needs and overcoming resistance to standard-of-care treatment in numerous patients. However, the development of unwanted immune responses directed against these drugs, humoral and/or cellular, can hinder their efficacy and have safety consequences with various degrees of severity. Health authorities ask that a thorough immunogenicity risk assessment be conducted during drug development to incorporate an appropriate monitoring and mitigation plan in clinical studies. With the rapid diversification and complexification of biologics, which today include modalities such as multi-domain antibodies, cell-based products, AAV delivery vectors, and nucleic acids, developers are faced with the challenge of establishing a risk assessment strategy sometimes in the absence of specific regulatory guidelines. The European Immunogenicity Platform (EIP) Open Symposium on Immunogenicity of Biopharmaceuticals and its one-day training course gives experts and newcomers across academia, industry, and regulatory agencies an opportunity to share experience and knowledge to overcome these challenges. Here, we report the discussions that took place at the EIP’s 14th Symposium, held in April 2023. The topics covered included immunogenicity monitoring and clinical relevance, non-clinical immunogenicity risk assessment, regulatory aspects of immunogenicity assessment and reporting, and the challenges associated with new modalities, which were discussed in a dedicated session.
