Biosimilars: Structural Characterization and Comparability Approaches
Event Date: April 26, 2012 at 11:00 AM EDT for North America and on May 3, 2012 at 11:00 AM CET for Europe

The regulatory pathway for biosimilar products, the Biologics Price Competition and Innovation Act, was approved in 2010 in the United States and FDA has recently issued draft guidance for the industry to bring a biosimilar to market. In Europe, EMA has had a pathway in place since 2005 and has approved approximately 14 biosimilars to date. Also on the biosimilars regulatory landscape is the International Conference on Harmonization’s Q6B guideline on test procedures and acceptance criteria for biotechnological/biological products. As industry moves forward to develop, test, and market new biosimilars at the global level, structural characterization of these products according to regulatory expectations will be crucial.

This webinar will provide information on how to approach biosimilar characterization and comparability to originator molecules. In addition, the webinar will provide an overview of the current regulatory expectations and plans for biosimilars in the US and European Union.

Speakers:

Gillian Woollette
, Vice-President, Avalere Health

Fiona Greer, PhD, Global Director, BioPharma Services Development, SGS M-Scan


Moderator:

Susan J. Schniepp
, Vice-President of Quality, OSO Biopharmaceuticals



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This is a FREE streaming audio Webcast and does not require a phone line. If you have any questions regarding this Webcast, please contact Jamie Carpenter, jcarpenter@advanstar.com.

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