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Successes and Challenges in Pharmacovigilance for Biologics and Biosimilars
Session Chair(s)
Brad Jordan, PhD
Associate Vice President, Regulatory Policy and Strategy
Eli Lilly and Company, United States
With the advent of biosimilars on a global scale and thus the introduction of multi-source biological products, the importance of accurate pharmacovigilance and unique product traceability cannot be understated. Not only do these efforts support detection of adverse drug reactions, they give confidence to providers and patients in the safe and appropriate use of these medicines. Various approaches have been taken in attempts to facilitate unique product traceability and improve risk minimization.
This session will focus on some of these approaches and their effectiveness and will highlight the role of National Regulatory Authorities and evolving technology infrastructure to improve traceability and enable global harmonization in these approaches.
Learning Objective : Describe the current state of pharmacovigilance efforts for biological products in various regions; Identify different approaches to unique product traceability and determine their effectiveness; Discuss how to help to identify opportunities for global harmonization to facilitate unique product identification.
Speaker(s)
Analysis of Biosimilars Approved in EU and US: Insights into Risk Minimization Strategies
Kalindi Hapani, MPharm
APCER Life Sciences, United Kingdom
Deputy Manager, Pharmacovigilance
Biosimilars: Should They Have a ‘Similar’ System to the Originator?
Brian Edwards, DrMed
International Society of Pharmacovigilance, United Kingdom
Vice President
FDA Perspective
Lubna Merchant, PharmD, MS
Pfizer Inc , United States
Director, Risk Management Center of Excellence
Biologic and Biosimilar Nomenclature: How Important is Distinguishability and International Harmonization?
Philip James Schneider, MS, RPh
Alliance for Safe Biologic Medicines, United States
Chair, Advisory Board
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