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Session 6: Identical Cousins: Generics and Biosimilars
Session Chair(s)
Mouna Akacha, PhD
Group Head of Statistical Methodology
Novartis Pharma AG, Switzerland
Jingyu (Julia) Luan, PhD
Senior Director, Global Regulatory Affairs, BioPharmaceuticals R&D
AstraZeneca, United States
This session will discuss similarities and differences in the statistical evaluation of generic drugs and biosimilars. According to the 2016 Generic Drug Savings and Access in the United States Report published by the Generic Pharmaceutical Association, generic drugs make up 89% of prescriptions dispensed but only 27% of total medicine spending. With the passage of Generic Drug User Fee Act II (GDUFA II), there is an increased emphasis on research for generic drugs. Likewise, statistical research in the field of biosimilars has recently received increasing attention. This session includes two presentations followed by a panel discussion. The first presentation will show the history and statistical issues for bioequivalence studies and the second presentation will discuss bioequivalence and biosimilarity evaluations. Panelists will discuss recent developments in these fields in light of the new initiatives and impact of GDUFAII.
Learning Objective : At the conclusion of this session, participants should be able to:- Describe the history and key statistical issues of bioequivalence studies
- Understand the main features of biosimilar drug development and the concept of “switchability” between the innovator biologic and its biosimilar
Speaker(s)
Some History and Statistical Issues for Bioequivalence Studies
Donald J Schuirmann, MS
U.S. Food and Drug Administration, United States
Associate Director
A Brief Introduction to Biosimilar Drug Development
Byron Jones
Statistical Methodology and Consulting Group, Novartis Pharma AG, Switzerland
Executive Director
Panelist
Stella C. Grosser, PhD, MS
FDA, United States
Division Director, Office of Biostatistics, OTS, CDER
John Peters, MD
John Peters, MD
FDA, United States
Deputy Director, Office of Generic Drugs, CDER
Shein-Chung Chow, PhD
Shein-Chung Chow, PhD
Duke University, United States
Professor, Department of Biostatistics and Bioinformatics, School of Medicine
Thomas E. Gwise, PhD
Thomas E. Gwise, PhD
FDA, United States
Division Director, Division of Biometrics IX, OTS, CDER
Larry Gould, PhD
Larry Gould, PhD
Merck Research Laboratories, United States
Sr. Director, Scientific Staff
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