Recent FDA biosimilar guidance emphasizes analytical similarity and risk based justification, enabling developers to streamline or waive comparative clinical studies when uncertainty is minimized. This talk outlines how process development teams can leverage this guidance to accelerate equivalence demonstrations by integrating advanced analytics, structure-function understanding, and targeted control strategies early in development. We will also highlight how Cytiva's regulatory services can support teams in interpreting FDA expectations, designing similarity packages, and implementing compliant, efficient development pathways.
Sandra Racordon
Director, Regulatory Science and Strategy & Cytiva
Sandra leads a team of regulatory professionals at Cytiva that partners with scientific and strategic experts across Cytiva to optimize regulatory support for innovation and growth. Particularly, Sandra and her team have worked on approaches to enable Cytiva product and their customers to meet regulatory goals.