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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.

Registration

This virtual workshop is open to the public and there is no cost to attend, but registration is required at the following: https://fda.zoomgov.com/webinar/register/WN_50JW87sSQ_exfaRXaOguPg. This workshop will be held in a virtual format only through a Zoom webcast.  After registering, you will receive a confirmation email containing information about joining the webinar.

Time

7:00 am-10:00 am US Eastern Time (ET)

1-4 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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