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          FDA Workshop: Increasing the Efficiency of Biosimilar Development Programs - 09/19/2022News & Events for Human Drugs Virtual
    Event Title
              FDA Workshop: Increasing the Efficiency of Biosimilar Development Programs


                  September 19, 2022

  

    
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      Meeting Information
                Event MaterialsDate:
          
  


     
           

September 19, 2022   

 
 
        
                                      Time: 
                                      
9:00 AM
    - 4:00 PM
ET

 

  **Background**

The U.S. Food and Drug Administration (FDA) is hosting a virtual public workshop on September 19, 2022, “Increasing the Efficiency of Biosimilar Development Programs.” The workshop will focus on comparative clinical studies associated with biosimilar development programs and will discuss possible innovative ideas that have the potential to streamline and improve the efficiency of biosimilar development. The workshop agenda includes detailed discussions on the statistical methods and approaches for these studies, including the Bayesian integration of various data sources to inform the design of the comparative clinical study. Additional discussions will focus on other clinical study design elements and recommendations to help increase the efficiency of these studies, such as the selection of endpoints. 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 FDA staff as well as external subject matter experts in the area of biostatistics. Interested audience members for this workshop includes biosimilar developers, academic researchers, and other stakeholders.

**Workshop Materials**

Agenda
	Presentation Slides (PDF - 6 MB)
	Zoom Recording
	Note: The workshop recording is split into two separate recordings. The 1st recording covers from 9am until 1pm. The 2nd recording covers from 1pm until the workshop's conclusion, and it starts automatically upon completion of the 1st recording. If you would like to advance to the 2nd recording, click the “Forward” icon located to the right of the “Play” or “Pause” icon in the bottom toolbar. To return to the 1st recording, click the “Backward” icon located to the right of the “Play” or “Pause” icon in the bottom toolbar.**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_Wnw0pEj7QY-qvKTdOO7oLA. This workshop will be held in a virtual format only through a Zoom webcast—after registering, you will receive an email that includes the link to join the workshop on September 19, 2022.

**Questions**

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





Event Materials

  Title
            File Type/Size09192022 FDA Workshop Increasing the Efficiency of Biosimilar Development Programs Agenda
              pdf               (187.60 KB)Compiled Final Slides_09192022 FDA Workshop Increasing the Efficiency of Biosimilar Development Programs
              pdf               (7.20 MB)

                                                                                  Content current as of:
      11/16/2022
         
                   
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