Rationalizing Biological Drug Development: Biosimilar Science, Modality-Specific Pathways, and the Bioprocessing Revolution, Part 2

Advances in analytical capabilities and emerging modalities are urging a reconsideration of how biosimilarity is demonstrated and regulated. Having laid the foundation for an approach based on modality-specific…

Advances in analytical capabilities and emerging modalities are urging a reconsideration of how biosimilarity is demonstrated and regulated. Having laid the foundation for an approach based on modality-specific exposure-anchored equivalence, the author turns to practical matters, including the role that AI could play in integrating and analyzing evidence of biosimilarity, implications for regulation, and consequences for the economics of biosimilar development.