Back to Agenda
Session 2: STATISTICAL APPROACHES IN BIOSIMILARITY
Session Chair(s)
Beatriz Seoane Núñez
Expert Statistician, AstraZeneca, Spain
Ferran Torres, PHD
Scientific Director, Biostatistics and Data, Clinic Hospital of Barcelona, Spain
A Biosimilar medicine is a growing field. The number of regulatory applications has increased in recent years. This session will highlight the features of the study design options for biosimilar efficacy trials. The choice of margins, their reliability and the different statistical and regulatory considerations associated with them will be some of the topics that will be discussed in this session from both a regulatory and industry point of view.
Speaker(s)
Peter Volkers
Biostatistician, Paul Ehrlich Institute, Germany
Statistical Challenges in Biosimilarity - a regulator’s view
Yulan Li
Biostatistician, Myovant Sciences, United States
Statistical Challenges and Current Experience in Biosimilarity Trial Designs
Have an account?