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FDA Latest Advances in the Approvals of Biosimilars

MessageThis Webinar is over
Date May 5, 2017
Time 05:30 AM EDT
Cost $249.00
Online
FDA Latest Advances in the Approvals of Biosimilars
Friday, 28th April, 2017 | 04:00 PM IST| 11:30 AM BST
REGISTER NOW!
The presentation will cover the following areas:
  • The submissions of biosimilars to the FDA which have taken place of US biosimilars that have not been submitted in the EU
  • FDA tackling monoclonal antibodies under abbreviated BLA’s
  • FDA approval of peglyated filgrastim leading to withdrawal of the ABLA
  • FDA publish long awaited interchangeability guidance in February 2017, with huge implications.
  • Various FDA guidances colelctively the recent clinical pharmacology one and interchangeability
  • EMA clinical basis of approval of 2016 biosimilars and the current most eminent pipeline
  • The current first ABLA reviews

 


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