Main topics of the Symposium

Biosimilars: Challenges and Regulatory Pathways

  • Introduction and use of biosimilars in Europe
  • Regulatory and market concerns
  • Regulatory landscape in Europe and USA
  • WHO Standard for regulatory evaluation biotherapeutics including biosimilars
  • Evaluation of monoclonal antibodies developed as biosimilars: WHO approach

Non-Biological Complex Drugs

  • Complex peptide mixtures
  • Liposomes
  • Complex ocular emulsions
  • Iron carbohydrate complexes
  • Nanomedicines

Advances in Bioanalytical Testing

  • Drug release from nano medicines
  • “Non-inferiority” assessment
  • Size and charge measurement of nanoparticulate system
  • The man and his spectrometer: a human-centered modus operandi of structure elucidatiuon by NMR and MS in Biosimilars
  • Bioanalytical challenges for biologics, biosimilar, non-biological complex drugs
  • Analytical toolbox for proteins: moving to full characterization
  • Semi-quantitative extractables & leachables (E&Ls) in protein preparations

Bioequivalence/Biosimilarity of Complex Drugs

  • Equivalence of generic complex drug products
  • Challenges in the assessment of similarity or equivalence of complex drugs
  • Biosimilar version of infliximab

Compendial Approaches

  • Ensuring the quality and safety of complex drugs:
    the international landscape of pharmacopeias

Clinical Aspects

  • Equivalence and interchangeability of complex drugs
  • Precision medicine, personalized targeted therapy against the driver genes and related pathways