Session 3: Streamlining Biosimilar Clinical Development

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Session 3: Streamlining Biosimilar Clinical Development

Session Chair(s)

Cecil J. Nick, MS

FTOPRA, Vice President (Technical)

Parexel Consulting, United Kingdom

This session addresses ways in which the clinical development of biosimilars can be streamlined exploring issues at to what extent current study designs contribute data that add value to the biosimilarity assessment. In particular is therapeutic equivalence adding value and to what extent CMC, PK and immunogenicity data can address therapeutic effect without the need for direct therapeutic equivalence trials.

Learning Objective : At the conclusion of this session, participants should be able to:
Appraise the clinical data requirements to support determination of biosimilarity
Justify situations where therapeutic equivalence data may not be required
Design and justify an optimal clinical development program to support determination of biosimliarity

Speaker(s)

The Path Towards a Tailored Clinical Biosimilar Development

Martin Schiestl, PhD

Sandoz GmbH, Austria

Global Head Regulatory Affairs Policy

Regulatory Expectations for Supporting Efficacy, Safety, and Immunogenicity of Biosimilars in the Clinic

Andrea Laslop, MD

Austrian Medicines and Medical Devices Agency, Austria

Head of Scientific Office

Applying Experiences with Udencya to Streamline Future Biosimilar Clinical Development

Barbara K Finck, MD, RN

Coherus, United States

CMO

Biosimilars Conference