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Session 3: Clinical and Pharmacology Considerations
Session Chair(s)
Cecil J. Nick, MS
FTOPRA, Vice President (Technical)
Parexel Consulting, United Kingdom
The role of clinical data in the development of biosimilars is to address any residual uncertainty following the generation of extensive structural and biological comparative data against the reference product, as well as some limited nonclinical data. In this respect, PK/PD and immunogenicity data could be sufficient, while in other circumstances, limited therapeutic data generated in an adequately sensitive patient population may be needed. There are numerous challenges in designing and conducting therapeutic equivalence trials, and their importance in establishing biosimilarity is sometimes overplayed. This session will consider when therapeutic trials may be needed and what value they play as part of the total biosimilarity data package.
Speaker(s)
Maximizing the Value of PK/PD in the Development of Biosimilarity
Jan Hillson, MD
Momenta Pharmaceuticals, Inc., United States
Senior Director of Clinical and Research
The Role of Pharmacology Data in Establishing Biosimilarity
Darrell R. Abernethy, MD, PhD
FDA, United States
Associate Director for Drug Safety, Office of Clinical Pharmacology, CDER
The Importance of Immunogenicity Data
Meena Subramanyam
Biogen Idec Inc., United States
Vice President, Development Translational Medicine
Extrapolation Across Indications
Bernd Liedert
Boehringer Ingelheim Pharma Gmbh & Co. KG Medicine, United States