Learning Tracks

This session will examine how recent regulatory developments are reshaping expectations for streamlined biosimilar development and what ICH M18 must deliver to support meaningful global convergence. Panelists will discuss FDA’s evolving recommendations on comparative efficacy studies, the use of non-U.S. comparator data, and the shift toward advanced analytical characterization and pharmacokinetic data as central elements of biosimilar development. The session will also explore how EMA’s recent policy direction aligns with these developments and whether ICH M18 can establish a sufficiently clear and practical framework to reduce divergent implementation across jurisdictions. With GRx+Biosims 2026 occurring during the ICH M18 drafting window, this session will provide an opportunity to identify industry priorities before key positions become settled.