Author: [AUTHOR] Published on 7/22/2022 12:00:00 AM
FDA to Hold Public Workshop to Discuss Biosimilar Product Development
The US Food and Drug Administration is hosting a one-day virtual public workshop entitled, “Increasing the Efficiency of Biosimilar Development Programs,” on Monday, September 19, 2022. Registration is now open, and details are below.
This public workshop will discuss statistical, scientific, and clinical methods for streamlining comparative clinical studies associated with biosimilar product development programs. This workshop will support the sharing of innovative ideas on the statistical approaches and clinical study design elements for streamlining these comparative clinical studies, which are the most expensive and operationally complex aspects of product development programs. Examples of these ideas include reducing sample sizes or modifying certain aspects of study designs that could improve the efficiency of biosimilar development overall. The workshop will be held virtually for participants and will include presentations and panel discussions from speakers and panelists from the FDA, as well as external subject matter experts in biostatistics. This workshop will be of particular interest to biosimilar developers, academic researchers, and other stakeholders.
Workshop Details and Registration Information
Date: September 19, 2022
Time: 09:00 am – 4:00 pm ET
Location: Virtual – Zoom webcast
This virtual workshop is open to the public; however, registration is required at: https://fda.zoomgov.com/webinar/register/WN_Wnw0pEj7QY-qvKTdOO7oLA
Please visit: https://www.fda.gov/drugs/news-events-human-drugs/fda-workshop-increasing-efficiency-biosimilar-development-programs-09192022/
for additional information about this workshop. This webpage will be updated to include workshop materials and any updated information as we approach the workshop date.
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This communication was prepared by Office of Clinical Pharmacology, Office of Translational Sciences, CDER, FDA.