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Bethesda North Marriott Hotel and Conference Center

23 abr 2018 1:00 p.m. - 25 abr 2018 4:15 p.m.

5701 Marinelli Road, , North Bethesda, MD 20852 , USA

DIA/FDA Biostatistics Industry and Regulator Forum

Session 6: Identical Cousins: Generics and Biosimilars

Session Chair(s)

Mouna  Akacha, PhD

Mouna Akacha, PhD

Group Head of Statistical Methodology

Novartis Pharma AG, Switzerland

Jingyu (Julia)  Luan, PhD

Jingyu (Julia) Luan, PhD

Executive Regulatory Science Director, 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)

Donald J Schuirmann, MS

Some History and Statistical Issues for Bioequivalence Studies

Donald J Schuirmann, MS

U.S. Food and Drug Administration, United States

Associate Director

Byron  Jones

A Brief Introduction to Biosimilar Drug Development

Byron Jones

Statistical Methodology and Consulting Group, Novartis Pharma AG, Switzerland

Executive Director

Stella C. Grosser, PhD, MS

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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