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Suffix or Superfluous? Evaluating FDA’s Biologics Naming Convention
Session Chair(s)
Stacey Ricci
Director, Scientific Review Staff, OTBB, CDER
US FDA, United States
This session explores pharmacovigilance for biosimilars, focusing on how FDA’s suffix-based naming and surveillance are implemented in practice. Panelists from FDA, academia, and industry will discuss suffix-related challenges and future directions.
Learning Objective : Describe the FDA’s nonproprietary naming convention for biological products and its intended role in pharmacovigilance; Analyze empirical evidence from FAERS to evaluate how suffix reporting impacts pharmacovigilance activities; Assess the role of naming conventions in broader active surveillance systems, such as the Sentinel System, and their implications for biosimilar safety monitoring.
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