Pharmacodynamic Biomarkers for Biosimilar Development and Approval


Public Workshop

Pharmacodynamic Biomarkers for Biosimilar Development and Approval

September 20, 2021 10:00AM - September 21, 2021 2:30PM

Zoom Webinar

Contact Information

Luke Durocher, Events and Marketing Manager

Workshop Description

Duke Margolis and the U.S. Food and Drug Administration (FDA) are hosting a public workshop September 20 and 21, 2021 on pharmacodynamic (PD) biomarkers for biosimilar development and approval. The workshop will feature several sessions moderated by Former FDA commissioner Dr. Mark McClellan. Sessions will focus on: 

  • Current and potential future state of leveraging PD biomarkers for biosimilar development and approval 
  • The FDA’s initiatives to advance biosimilar development 
  • Stakeholders’ experience with PD biomarkers in biosimilar development  
  • Research efforts that will promote a broader application of PD biomarkers in biosimilar development 


Agenda and Speakers

An agenda preview will be published on this website in the coming weeks. Selected speakers will be announced on a rolling-basis and a full workshop agenda and speaker list will be published closer to the workshop date. 


Funding for this workshop was made possible in part by a cooperative agreement from the U.S. Food and Drug Administration Center for Drug Evaluation and Research. The views expressed in written workshop materials or publications and by speakers and moderators do not necessarily reflect the official policies of the Department of Health and Human Services nor does mention of trade names, commercial practices, or organizations imply endorsements by the U.S. Government.

Duke-Margolis Team

Image of Nicholas Harrison

Nicholas R. Harrison, MPH, MA

Senior Policy Analyst

Photo of Valerie Parker

Valerie Parker

Policy Analyst


Adam Kroetsch, MPP

Research Director, Biomedical Innovation and Regulatory Policy
Senior Team Member