Joint DIA/AEMPS Statistics Workshop

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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)

Statistical Challenges in Biosimilarity - a regulator’s view

Peter Volkers

Paul Ehrlich Institute, Germany

Biostatistician

Statistical Challenges and Current Experience in Biosimilarity Trial Designs

Yulan Li

Myovant Sciences, United States