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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  Luan, PhD

      Jingyu Luan, PhD

      • Lead Mathematical Statistician
      • 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.

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Submission Deadline: February 12