Advancing Biosimilar Development Using Pharmacodynamic Biomarkers in Clinical Pharmacology Studies.

To ensure US patients realize the public health benefit of a robust, competitive market for biosimilar products, the US Food and Drug Administration (FDA) is focused on improving the efficiency of biosimilar development and approvals. As comparative clinical studies can be costly and time consuming, the FDA is currently conducting research to inform the agency's thinking on critical aspects of the use of pharmacodynamic (PD) biomarkers to demonstrate biosimilarity, which can either streamline or negate the need for comparative clinical studies.