On-Demand Webinar: What the New AAPS White Paper Recommends for Immunogenicity Assays Supporting Biosimilars

The demonstration of similar immunogenicity is a critical requirement for the demonstration of similarity between a biosimilar candidate and the respective reference product. While recent progress has been made in describing and understanding the challenges of the assessment of anti-drug antibodies (ADAs) in support of biosimilar programs in the clinical setting, lack of specific guidance on development and validation requirements for immunogenicity assessments of biosimilars and reference biologics in comparability studies has led to the use of different approaches in different programs.