Strategic Considerations for Developing an Initial Pediatric Study Plan for a Proposed Biosimilar

Time

Wed, Jun 17 9:00AM
W 15

Title

Strategic Considerations for Developing an Initial Pediatric Study Plan for a Proposed Biosimilar

Abstract Summary

ORAL PRESENTATION SCHEDULED: Wednesday, June 17 in Session #2B at 11:42 - 11:47 am in the Exhibit Hall Poster Area (Hall A entrance)

Various regulatory scenarios are considered;1) pediatric indications for which the reference product was approved, 2) pediatric indications for which the reference product has been studied but did not get approved, 3) pediatric age groups that are required to be addressed based on FDASIA.

Poster Presenter

Sally Choe
PhD, MS,
Senior Director,
PAREXEL International
United States