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Pharmacodynamic Biomarkers for Biosimilar Development and Approval: A Workshop Summary

Jeffry Florian1, Qin Sun2, Sarah J Schrieber3

  • 1Division of Applied Regulatory Science, Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.

Clinical Pharmacology and Therapeutics
|November 16, 2022
PubMed
Summary

Pharmacodynamic (PD) biomarkers can streamline biosimilar development and approval, aligning with FDA guidance. A workshop convened experts to discuss leveraging PD biomarkers for more efficient biosimilar pathways.

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