- September 19, 2022
- 9:00 AM - 4:00 PM ET
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, to include an agenda and slide presentations, will be posted on this page no later than five days before the workshop. Please visit this page for any updates.
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.
Office of Therapeutic Biologics and Biosimilars
Office of New Drugs
Center for Drug Evaluation and Research