Canadian Perspectives on Using Pharmacodynamic Markers for Biosimilar Development and Authorization

This narrative review summarizes Health Canada's perspective on the clinical development of biosimilars and related scientific and regulatory challenges on the use of pharmacodynamic (PD) markers, and what we may have learned from using them. New discriminatory and sensitive PD markers should be explored. Defining a collectively agreed approach for the use of PD markers is needed to remove hurdles faced in biosimilar development irrespective of whether we are using PD surrogates or PD biomarkers.

Automated summary

This narrative review summarizes Health Canada's perspective on the clinical development of biosimilars and related scientific and regulatory challenges on the use of pharmacodynamic markers, and what we may have learned from using them.