U.S. flag An official website of the United States government

On Oct. 1, 2024, the FDA began implementing a reorganization impacting many parts of the agency. We are in the process of updating FDA.gov content to reflect these changes.

U.S. Food and Drug Administration
  1. Home
  2. Drugs
  3. News & Events for Human Drugs
  4. Pharmacodynamic Biomarkers for Biosimilar Development and Approval - 09/20/2021 - 09/21/2021
  1. News & Events for Human Drugs

Virtual | Virtual

Event Title
Pharmacodynamic Biomarkers for Biosimilar Development and Approval
September 20 - 21, 2021

Date:
September 20 - 21, 2021
Day1:
Mon, Sep 20
Day2:
Tue, Sep 21

Location: Virtual   

The U.S. Food and Drug Administration (FDA) in collaboration with Duke-Margolis will host a two-day virtual public workshop entitled “Pharmacodynamic Biomarkers for Biosimilar Development and Approval” on September 20 – 21, 2021. This public workshop is a forum for regulators, biopharmaceutical developers and academic researchers to discuss the current and future role of pharmacodynamic (PD) biomarkers in improving the efficiency of biosimilar product development and approval.

Workshop Objectives:  

  • Discuss the current and potential future state of leveraging PD biomarkers for biosimilar development and approval 
  • Summarize FDA’s initiatives to advance biosimilar development 
  • Describe stakeholders’ experience with PD biomarkers in biosimilar development  
  • Explain research efforts to promote a broader application of PD biomarkers in biosimilar development 

  
Meeting Information and Registration: This workshop is open to the public with no cost to attend, but registration is required. To see the agenda and register, visit the 
workshop page. 

Questions: For questions regarding this event, please send an email to luke.durocher@duke.edu

 

 

Back to Top