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DIA/FDA Biostatistics Industry and Regulator Forum

Session 6: Identical Cousins: Generics and Biosimilars

    Session Chair(s)
      Mouna  Akacha, PhD

      Mouna Akacha, PhD

      • Statistical Methodologist
      • Novartis Pharma AG, Switzerland
      Jingyu (Julia)  Luan, PhD

      Jingyu (Julia) Luan, PhD

      • Deputy Division Director (Acting), OB, OTS, CDER
      • FDA, 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
      Donald J Schuirmann, MS

      Some History and Statistical Issues for Bioequivalence Studies

      Donald J Schuirmann, MS

      • Associate Director
      • U.S. Food and Drug Administration, United States
      Byron  Jones

      A Brief Introduction to Biosimilar Drug Development

      Byron Jones

      • Executive Director
      • Statistical Methodology and Consulting Group, Novartis Pharma AG, Switzerland
      Stella C. Grosser, PhD


      Stella C. Grosser, PhD

      • Division Director, Office of Biostatistics, OTS, CDER
      • FDA, United States
      John  Peters, MD

      John Peters, MD

      • Deputy Director, Office of Generic Drugs, CDER
      • FDA, United States
      Shein-Chung  Chow, PhD

      Shein-Chung Chow, PhD

      • Associate Director, OB, OTS, CDER
      • FDA, United States
      Thomas E. Gwise, PhD

      Thomas E. Gwise, PhD

      • Deputy Division Director, Division of Biometrics V, CDER
      • FDA, United States
      Larry  Gould, PhD

      Larry Gould, PhD

      • Sr. Director, Scientific Staff
      • Merck Research Laboratories, United States