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?