IPRP Biosimilars Working Group (BWG) Workshop - Updated

Submitted by n.luludi on Mon, 06/26/2023 - 14:54

The IPRP Biosimilars Working Group (BWG) is hosting a virtual workshop "Increasing the Efficiency of Biosimilar Development Programs-Reevaluating the Need for Comparative Clinical Efficacy Studies" on September 12-13, 2023, 1300-1600 Central European Time (CET).  The public sessions of the workshop will include discussion of the experience accrued with comparative clinical efficacy studies to date and stakeholder perspectives on the question of whether these studies are needed.


Please find the agenda with a list of topics that will be discussed here.


The workshop will include presentations and panel discussions by international regulatory experts as well as external subject matter experts in the area of biosimilar development and the role of comparative clinical efficacy studies. Interested audience members for this workshop includes biosimilar developers, academic researchers, and other stakeholders.


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_50JW87sSQ_exfaRXaOguPg

This workshop will be held in a virtual format only through a Zoom webcast.  After registering, you will receive a confirmation email containing information about joining the webinar.


For questions please contact: CDER-BiologicsBiosimilarsInquiries@fda.hhs.gov