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In Vitro and In Vivo Preclinical Testing of Biosimilars: What Have We Learned?
Session Chair(s)
David Jones, MS
Consultant, Regulatory Pharmaco-Toxicologist, ApconiX, United Kingdom
This session will examine the nonclinical requirements for the safety assessment of biosimilars. We will also review EU and US regulatory requirements and efforts to harmonize approaches.
Learning Objective : Review nonclinical testing requirements for biosimilars; Discuss EU regulatory requirements; Discuss US regulatory requirements.
Speaker(s)
Introduction to Biosimilars and Global Regulatory Guidelines
David Jones, MS
Consultant, Regulatory Pharmaco-Toxicologist, ApconiX, United Kingdom
Comparing Complex Medicines Using Multisystem Gene Expression Profiling: A Critical Piece of the “Sameness” Puzzle
Iris Grossman, PhD
Vice President, Global Head of Personalized Medicine and Pharmacogenomics, Teva Pharmaceutical Industries Ltd., Israel
Animal Studies With Biosimilars: Where Do We Stand?
Paul Baldrick, PhD
, Covance Inc., United Kingdom
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