530 Broadway Street
San Diego, California 92101

Course Description:

Analytical Strategy is a critical element of Biosimilar product development plan. A comprehensive Analytical package which meets current regulatory expectations will minimize the amount of clinical studies and therefore control costs of the Biosimilar development program.

This is a rapidly evolving topic and the industry needs to keep up with the current expectations. The draft Revision1 of the EU Biosimilar Quality guidance was issued in May 2012 and is currently open for comments. The FDA guidance on Quality Considerations in Demonstrating Biosimilarity To a Reference Protein Product is expected this year. Other regions of the world continue to publish Biosimilar Guidance and their revisions and several scientific publications which present the industry point of view have been published recently.

Learning Objectives:

This workshop will provide the audience with:

- An overview of the current status of Global Biosimilar Guidance with a focus on the Analytical Package required for a Biosimilar product.
- The Analytical comparability studies currently required for comparison of the Reference Product with the Biosimilar will be discussed.
- The Analytical methods and specifications required for both comparability studies and lot release and stability studies will be addressed.

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Added by complianceonlinecom on March 14, 2013