Virtual | Virtual

Event Title

FDA Workshop: Increasing the Efficiency of Biosimilar Development Programs

September 19, 2022

Date:: 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 Research
CDER-BiologicsBiosimilarsInquiries@fda.hhs.gov

Event Materials

Title	File Type/Size
09192022 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)