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Session 3: Streamlining Biosimilar Clinical Development
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
The Path Towards a Tailored Clinical Biosimilar Development
Martin Schiestl, PhD
- Global Head Regulatory Affairs Policy
- Sandoz GmbH, Austria
Regulatory Expectations for Supporting Efficacy, Safety, and Immunogenicity of Biosimilars in the Clinic
Andrea Laslop, MD
- Head of Scientific Office
- Austrian Medicines and Medical Devices Agency, Austria
Applying Experiences with Udencya to Streamline Future Biosimilar Clinical Development
Barbara K Finck, MD, RN
- Coherus, United States