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#528: Suffix or Superfluous? Evaluating FDA’s Biologics Naming Convention
Tuesday June 16, 2026 1:45pm - 3:00pm EDT
118AB
Component Type: Session
Level: Advanced
CE: ACPE 1.25 Knowledge UAN: 0286-0000-26-569-L04-P; CME 1.25; RN 1.25

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 Objectives

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.

Chair

Stacey Ricci, DRSC

Speaker

TBD
Mary Jo Carden, JD

TBD
Judith Maro, MS

TBD
Mariana Socal, MD, PHD, MS


Speakers
avatar for Mary Jo Carden

Mary Jo Carden

Carden Associates, United States
Mary Jo Carden is President of Carden & Associates. She previously served as Head of Policy at Sandoz, Inc., Vice President of Government and Pharmacy Affairs at AMCP. She has also served as Director of Regulatory Affairs at Medco Health Solutions, in various government affairs capacities... Read More →
avatar for Judith Maro

Judith Maro

Associate Professor, Department of Population Medicine, Harvard Medical School, United States
Dr. Maro is an Associate Professor in the Department of Population Medicine at Harvard Medical School and the Harvard Pilgrim Health Care Institute. She received her doctorate in Engineering Systems at the Massachusetts Institute of Technology (MIT). She is a site principal investigator... Read More →
avatar for Stacey Ricci

Stacey Ricci

Director, Scientific Review Staff, OTBB, CDER, FDA, United States
As Director of the Scientific Review Staff in the Office of Therapeutic Biologics and Biosimilars (U.S.FDA/CDER), Dr. Ricci leads a team of scientists, clinicians, pharmacists, and project managers who oversee the review of biosimilar products at all stages of development, advance... Read More →
avatar for Mariana Socal

Mariana Socal

Associate Professor, Johns Hopkins Bloomberg School of Public Health, United States
Dr. Socal is an associate professor at the Johns Hopkins Bloomberg School of Public Health. Prof. Socal researches ways to improve access and affordability of prescription drugs, including generics and biosimilars, gene therapies, insulins, and the global pharmaceutical supply chain... Read More →
Tuesday June 16, 2026 1:45pm - 3:00pm EDT
118AB The Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 USA
  01: ClinSafety-PV-RM, Session
  • Audience Advanced
  • Level Advanced
  • format csv
  • Credit Type ACPE, CME, RN
  • Interest Area Clinical Safety & Pharmacovigilance
  • Tags Session

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