Contents

General interest

0. Foreword – Paul Declerck, University of Leuven

1. Current regulatory landscape for biosimilar approval – Begoña Calvo, University of the Basque Country

  • Worldwide regulatory framework for biosimilars with special emphasis in European guidelines for biosimilars development
  • Need of harmonization of regulatory processes across the US, Europe and Japan

2. Overview of biosimilars development – LingSing Chen, QPS

3. Case studies: EU regulatory guidelines and how to interpret them – Jun Wang, Duke University

4. Analytical comparability (CMC related product attributes) – Ashleigh Wake, Intertek

5. Key factors that influence biosimilar in vitro and in vivo nonclinical testing strategies – Kelly S. Colletti, Charles River Laboratories

6. Immunogenicity assessment for biosimilars – assay development, validation and interpretation – James Munday, Covance

  • Immunogenicity assessment of biosimilars:
    • Clinical consequences for efficacy and safety
    • Regulatory Guidance
  • Advantages and disadvantages of the different bioanalytical approaches used in immunogenicity assays
  • Immunogenicity assay development and validation
    • ADA Screening assays
    • Neutralising antibody assays
  • Interpretation of Immunogenicity assays

7. Case studies: challenges of developing and validating PK and Immunogenicity assays to support pre-clinical and clinical comparability studies for biosimilars – Xiao-Yan Cai, WuXi AppTec Global Bioanalytical Services, and Dominique Gouty, BioAgilytix Laboratories

  • Establishing biosimilarity of a biosimilar drug to its originator entails a broad range of assessments that may include molecular analysis, efficacy and safety. Both pharmacokinetics (in drug adsorption, distribution, metabolism, and excretion) and immunogenicity are part of the efficacy and safety assessments through preclinical and clinical comparability studies in establishing similarities in comparison to the originator.
  • We will discuss industry consensus of using either a single assay or 2-assay systems when developing and validating the PK and immunogenicity assays to support comparability studies.
  • The challenges of establishing intra and inter-batch similarity between the biosimilar and its originator in both PK and immunogenicity assays will be presented as case studies.

8. Biosimilar monoclonal antibodies – Paul Declerck, University of Leuven

  • What are monoclonal antibodies?
  • How are they produced
  • Relationship between structure and molecular properties
  • Key elements in the demonstration of biosimilarity of MAs
  • Recently approved biosimilar MAs, lessons learned