Biosimilars Community Forum for an opened professional disscussion
Descussion about recent industry news, developments, interesting novelties ...
Handling of missing data issues ...
Effective research model building to handle complexity in public health studies,
Discussion about EU EMA Regulatory requirements
Discussion about US FDA Regulatory requirements
Discussion about WHO rules regarding biosimilar drug products
Development • Fundamental differences: Generics versus biosimilars • Regulatory requirements: EU EMA, US FDA, and WHO • Definition of biosimilarity: US BPCI Act • Scientific factors for assessing biosimilarity: Criteria for biosimilarity | Non-inferiority vs. equivalence | Multiple reference products • Development of biosimilarity index: Unified and robust approach • Concluding remarks
ssues, Designs, and Statistical methods • Concept of interchangeability: Switching | Alternating • Current issues: Produce same clinical results in any given patient • Criteria for interchangeability: Adjust for variability of reference product • Study designs: Switching designs • Statistical methods • Concluding remarks
Analytical similarity assessment • Classification of critical quality attributes (CQAs) • Tiered approach – Equivalence test for Tier 1 CQAs – Quality range approach for Tier 2 CQAs – Raw data and graphical comparison for Tier 3 CQAs US FDA’s current thinking on Tiered approach
This is a simple parent forum