Canadian Perspectives on Using Pharmacodynamic Markers for Biosimilar Development and Authorization.

Although, when a PK/PD study cannot be conducted in HVs due to ethical considerations or an anticipated pharmacological effect, PK/PD studies should be conducted in the patient population. 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. [Extracted from the article]