TL12: Statistical Issues in the Approval of Biosimilars
*Eric M Chi, Amgen Inc.
Draft guidances for the approval pathway of biosimilars from the FDA have been released in February 2012. The decision rules, hence statistical methods, for the approval of biosimilars are of critical importance. Statistical issues, some may be particular to biological products, for the assessment of biosimilarity will be identified and discussed.
April 30 - May 22, 2013
Invited Abstract Submission Open
June 4, 2013
Online Registration Opens
August 9 - August 23, 2013
Invited Abstract Editing
August 23, 2013
Short Course materials due from Instructors
August 26, 2013
September 9, 2013
Cancellation Deadline and Registration Closes @ 11:59 pm EDT
September 16 - September 18, 2013
Marriott Wardman Park, Washington, DC