Back to Agenda
Session 1: Determining Biosimilarity: By Use of Totality of the Evidence
Session Chair(s)
Bruce P. Babbitt, PhD
Vice President - Technical (Drug Development and Regulatory Affairs)
PAREXEL Consulting, United States
In the US, Europe, and other regions, biosimilarity is demonstrated through a totality of evidence approach. This session will examine the picture of biosimilarity presented by the components of evidence, including the foundations laid by CMC/analytics, non-clinical data, analysis of critical quality attributes (CQAs), and clinical data to address the clinical relevance of differences, from the perspectives of the regulator and of industry. What is the regulator’s view of the organizing framework and how the data work together to demonstrate biosimilarity, especially for complex biologics? From the industry view, when is stepwise development preferable to a parallel development process, and how is decision making, about residual uncertainty or risk for example, influenced by each of these paradigms? What does the totality of evidence mean for development versus marketing applications? Global regulators will join the session speakers in an interactive panel discussion to address audience questions.
Speaker(s)
Regulators’ Perspective
Leah Christl, PhD
Amgen, United States
Exec Director, Global Biosimilars Regulatory Affairs & Regulatory & R&D Policy
Industry Perspective: Application of Regulation to Development
Lisa Bell, DrSc, PhD
Coherus BioSciences, United States
SVP Global Regulatory
Panel Discussion
All Session Speakers, United States
Panelist
Jian Wang, MD, PhD
Health Canada, Canada
Division Manager, Clinical Review Division – Heamatology/Oncology
Panelist
Hubert C Chen, MD
PFEnex Inc, United States
Chief Medical Officer
Panelist
Martina Weise, DrMed, MD
Bfarm, Germany
Head, Licensing Division 2, BfArM; German CHMP Alternate
Have an account?