DIA 48th Annual Meeting
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Update on Biosimilar Developments in the US
Track
:
Track 08: Regulatory Affairs and Submissions
Program Code:
384
Date:
Wednesday, June 27, 2012
Time:
3:30 PM to 5:00 PM
EST
CHAIR
:
Nikhil Mehta, Merck & Co., Inc., United States
PRESENTER
(S):
Mark McCamish, Sandoz Biopharmaceuticals, a Novartis Company, Germany Leah Christl, FDA, United States Jay Siegel, Johnson & Johnson, United States
Description
Statutory framework for biosimilars was approved in the US in March 2010. This session will discuss progress in defining regulatory standards for approval of biosimilars.
Learning Objectives:
Identify the progress in development of regulatory standards for biosimilars by FDA
Explain different approaches for biosimilar development and approval.
Learning Objectives:
Identify the progress in development of regulatory standards for biosimilars by FDA
Explain different approaches for biosimilar development and approval.
This session is a part of:
Handout Online
