FDA News: Issue 14-1 July 2022

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.

The Office of Clinical Pharmacology (OCP) is pleased to offer the e-mail subscription service Clinical Pharmacology Corner. This is a free service from FDA to provide occasional updates from OCP regarding newly approved therapies, new regulatory and scholarly publications, upcoming events and other items of interest. Subscribe today at https://public.govdelivery.com/accounts/USFDA/subscriber/topics and select Clinical Pharmacology Corner under Drugs.

We always welcome your thoughts regarding the format, content, and utility of this communication. Comments may be sent via email to ocp@fda.hhs.gov.

This communication was prepared by Office of Clinical Pharmacology, Office of Translational Sciences, CDER, FDA.

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