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Activity Number: 206
Type: Roundtables
Date/Time: Monday, August 10, 2015 : 12:30 PM to 1:50 PM
Sponsor: Biopharmaceutical Section
Abstract #316942
Title: Phase III Biosimilars Trials: Topics of Interest
Author(s): Lori Davis*
Companies: ProNAi Therapeutics
Keywords: Biosimilars ; Bioequivalence ; Adaptive design
Abstract:

The global market in biosimilars is expected to grow by about 20% between 2013 and 2018. With this fast growth, it is imperative that an awareness of the various challenges in this area develops. Within the CRO setting, this means helping sponsors understand the requirements on the path toward approval. This session is meant to gather individuals to discuss questions/topics specifically regarding phase III biosimilars trials. Items for discussion will include (1) The FDA requires justification of an appropriate equivalence margin. What approach(es) have been taken, and is there an agreed upon method? (2) How often is an asymmetric margin justifiable? (3) What adaptive design approaches (e.g., group sequential methods) might be incorporated?

Authors who are presenting talks have a * after their name.

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