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.
This presentation will discuss what the new AAPS White Paper, co-authored with the FDA and EMA, recommends for the development and validation of immunogenicity assays in support of biosimilar programs. It will also explore what it recommends for the use of a single, biosimilar-based assay for assessing immunogenic similarity in support of biosimilar drug development.
What will you learn?
- Learn more about the requirements for immunogenicity assessments of biosimilars and reference biologics in comparability studies in the clinical setting.
- Hear experts describe the challenges of the assessment of ADAs in support of biosimilar programs.
- Understand why the FDA and EMA recommend the use of a single, biosimilar-based assay for assessing immunogenic similarity in support of biosimilar drug development.
- See practical guidance for the development and validation of ADA assays to assess immunogenicity of a biosimilar in comparison to the originator using the one-assay approach.
Who may this interest?
- Bioanalytical scientists
- Regulatory specialists
- Quality managers
BioAgilytix (NC, USA)
Todd Lester is a seasoned biotechnology and pharmaceutical project management professional. In his role at BioAgilytix (NC, USA) he oversees and leads all technical aspects of complex bioanalytical studies including design, interpretation, analysis, documentation, and reporting of results, investigations and deviations.
Todd has broad GxP expertise and is well-versed in the regulations and filing requirements for FDA and EMA, particularly regarding biosimilar development and the related immunogenicity assessment strategy and data interpretation. Todd holds a Bachelor of Science in Biological Sciences from Cornell University (NY, USA) and is a licensed Project Management Professional (PMP) with the Project Management Institute (PMI).