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Session 4: The Role of Real-World Evidence (RWE) in the Post-Approval Setting
Session Chair(s)
Thomas Felix, MD
Medical Director, R&D Policy, Global Regulatory Affairs and Safety
Amgen Inc., United States
This session will explore the role of RWE in the post-approval setting for biosimilars. RWE can be used for a range of purposes that span product safety to commercial interests. The presentations and panel discussion will focus on the current state of RWE to inform pharmacovigilance, extrapolated indications, comparative effectiveness, product utilization, and value assessments. You will also assess the utility of the FDA’s Sentinel Initiative as a source for biologic and biosimilar studies. Other National regulatory authorities are empowered to conduct real-world analyses when similar national databases are developed and available for public health purposes.
Speaker(s)
Key Questions Stakeholders Ask About Biosimilars Post-Approval
Nancy A Dreyer, PhD, MPH, FISPE
Dreyer Strategies LLC, United States
Founder
Key Challenges to Addressing Post-Approval Biosimilar Questions
Brian Bradbury, DrSc, MA
Amgen, United States
Vice President, Center for Observational Research
Methodologies for Addressing CER/CSR: Strengths and Limitations
Alan Brookhart
University of North Carolina, Chapel Hill, United States
Professor, Department of Epidemiology, Gillings School of Global Public Health
Panel Discussion
All Session Speakers, United States