Bioequivalence Innovations for Oral Generic Products: Biowaivers, Bridging, and Generic Development for Oncology and Discontinued Products

This 2-day workshop will highlight innovative bioequivalence (BE) approaches for oral generic drug products when conventional in vivo BE studies may not be feasible, with an emphasis on oncology products and biopharmaceutics classification system (BCS) Class IV drugs. The workshop will explore biowaiver pathways supported by bio-predictive dissolution, absorption modeling, and model-integrated evidence. The program will also address strategies for bridging BE when designated reference standards are unavailable for discontinued products, when surrogate comparators are needed, and when nitrosamine-impacted drug products are reformulated. Sessions will highlight adaptive PK study designs, scientifically justified bridging approaches, and the regulatory considerations for implementing these alternative BE strategies. Data integrity, reproducibility, model credibility, and well-defined criteria will be emphasized for establishing BE in complex and challenging oral generic drug development scenarios.