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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
Executive Regulatory Science Director , 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
Associate Director, U.S. Food and Drug Administration, United States
A Brief Introduction to Biosimilar Drug Development
Byron Jones
Executive Director, Statistical Methodology and Consulting Group, Novartis Pharma AG, Switzerland
Panelist
Stella C. Grosser, PhD, MS
Division Director, Office of Biostatistics, OTS, CDER , FDA, United States
John Peters, MD
Deputy Director, Office of Generic Drugs, CDER, FDA, United States
Shein-Chung Chow, PhD
Professor, Department of Biostatistics and Bioinformatics, School of Medicine, Duke University, United States
Thomas E. Gwise, PhD
Division Director, Division of Biometrics IX, OTS, CDER, FDA, United States
Larry Gould, PhD
Sr. Director, Scientific Staff, Merck Research Laboratories, United States
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