Complex Primary Cell Assays - Strategic Tools for Biosimilar Comparability

Explore how complex primary cell assays serve as strategic tools for demonstrating biosimilar comparability in this 52-minute webinar presented by Fiona Miller, an immunology and pharmacology expert with over a decade of CRO experience. Learn about the evolving regulatory landscape following the recent EMA reflection paper that aligns with FDA and WHO positions, emphasizing the central role of pharmacokinetic data and analytical similarity in biosimilar development. Discover how regulators are increasingly adopting a "totality of evidence" approach that may allow for waiving Comparative Efficacy Studies (CES) when strong scientific justification exists. Understand why analytical data provides the critical "fingerprint-like" foundation for biosimilarity, often offering more insight than CES which can highlight irrelevant differences between biosimilars and reference products. Examine how complex primary cell assays, designed to closely mimic patient biology, can be strategically leveraged to complement analytical similarity data and demonstrate functional similarity, particularly for biologics with complex mechanisms of action. Gain insights into integrating these assays into predefined similarity assessment protocols to strengthen evidence packages, support regulatory confidence, and potentially streamline biosimilar development for complex modalities.