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

Presenter: Todd Lester, Associate Director at BioAgilytix

Co-Hosted with: Bioanalysis Zone

The demonstration of similar immunogenicity is a critical requirement for the demonstration of biosimilarity between a biosimilar candidate and the respective reference product. In their webinar, Mr. Lester discusses what the new AAPS White Paper recommends for immunogenicity assays supporting biosimilars., addressing questions such as:

  • What are the requirements for immunogenicity assessments of biosimilars?
  • Why do the FDA and EMA recommend the use of a single, biosimilar-based assay?
  • How are anti-drug antibody (ADA) assays developed and validated for the support of biosimilar drug development programs?
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