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  4. Increasing the Efficiency of Biosimilar Development Programs - Reevaluating the Need for Comparative Clinical Efficacy Studies - 09/12/2023
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Virtual | Virtual

Event Title
Increasing the Efficiency of Biosimilar Development Programs - Reevaluating the Need for Comparative Clinical Efficacy Studies
September 12 - 13, 2023

Date:
September 12 - 13, 2023
Day1:
Tue, Sep 12 7:00 a.m. - 10:00 a.m. ET
Day2:
Wed, Sep 13 7:00 a.m. - 10:00 a.m. ET

About

The U.S. Food and Drug Administration (FDA) and the International Pharmaceutical Regulators Program (IPRP) Biosimilars Working Group (BWG) is hosting a virtual workshop "Increasing the Efficiency of Biosimilar Development Programs--Reevaluating the Need for Comparative Clinical Efficacy Studies" on September 12-13, 2023.  The public sessions of the workshop will include discussion of the experience accrued with comparative clinical efficacy studies to date and stakeholder perspectives on the question of whether these studies are needed. 

A full list of topics that will be discussed will be detailed in the forthcoming agenda.

The workshop will include presentations and panel discussions by U.S. and international regulatory experts as well as external subject matter experts in the area of biosimilar development and the role of comparative clinical efficacy studies. Interested audience members for this workshop includes biosimilar developers, academic researchers, and other stakeholders.

Recordings

Workshop Summary Report

Time

  • 7:00 AM - 10:00 AM US Eastern Time (ET)
  • 1:00 PM - 4:00Ikenberry, Sarah PM Central European Time (CET)

Questions

Office of Therapeutic Biologics and Biosimilars
Office of New Drugs
Center for Drug Evaluation and Research
CDER-BiologicsBiosimilarsInquiries@fda.hhs.gov

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