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          Increasing the Efficiency of Biosimilar Development Programs--Reevaluating the Need for Comparative Clinical Efficacy Studies - 09/12/2023News & Events for Human Drugs Virtual
    Event Title
              Increasing the Efficiency of Biosimilar Development Programs--Reevaluating the Need for Comparative Clinical Efficacy Studies


                  September 12 - 13, 2023

  

    
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      Meeting Information
                Event MaterialsDate:
          
  


     
                                                       
       

September 12 - 13, 2023   

 
 
        
                
                                      Day1: 
              Tue, Sep 12 7:00 AM
 - 10:00 AM
 ET
            
                      Day2: 
              Wed, Sep 13 7:00 AM
 - 10:00 AM
 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

Day one
	Day twoRegistration

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







Event Materials

  Title
            File Type/SizeDraft Workshop Agenda for FDA IPRP Public Meeting
              pdf               (164.84 KB)FDA IPRP Public Meeting Combined Presentations Day 1
              pdf               (2.51 MB)FDA IPRP Public Meeting Combined Presentations Day 2
              pdf               (4.10 MB)

                                                                                  Content current as of:
      11/17/2023
         
                   
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