Perspective on Pharmacokinetic Comparability for Biologics Development.

Comparability assessment of biologics is essential to support manufacturing changes throughout drug development life cycle. Centering on pharmacokinetic comparability for biologics, this manuscript summarizes current and emerging insights drawing from a webinar hosted by the American Society for Clinical Pharmacology and Therapeutics Life Cycle Management Community. The common theme across industry and regulatory experiences is the use of risk-based, hierarchical approaches to bridge pre- and post-change products, ranging from foundational analytical comparability to clinical pharmacokinetic comparability studies.