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FDA Latest Advances in the Approvals of Biosimilars

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Description: FDA Latest Advances in the Approvals of Biosimilars

Friday, 28th April, 2017 | 04:00 PM IST| 11:30 AM BST


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

URL: http://www.biopractice.com/webinar/live/145
Date: Friday, May 5, 2017
Time: 4:00pm-5:00pm UTC
Duration: 1 hour
Access: Public
Created by: Public Access
Updated: Monday, May 1, 2017 7:34am UTC
Cost ($): €249
Call In Number: 6462168860
Contact Email: marketing.biopractice@gmail.com
Contact Person: Sachin
Contact Phone: 6462168860
Comments: None