FDA Draft Guidance's on Biosimilar Product Development

These are the first biosimilar guidelines to be published by the FDA. There are three draft guidance documents, which together provide FDA’s current thinking on approaches to demonstrate that a biological product is biosimilar to an FDA-approved biological product using the abbreviated pathway established under the Public Health Service Act:

Topics to be covered:

• Scientific Considerations in Demonstrating Biosimilarity to a Reference Product
• Quality Considerations in Demonstrating Biosimilarity to a Reference Protein Product
• Biosimilars:  Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009

Moderator

Tim Clark

Vice President Scientific Affairs
Global Scientific Council
ICON plc

Expert Panelists:

Stuart Madden
Vice-President Scientific Affairs
Global Scientific Council
ICON Clinical Research

Sandra Bihary-Waltz
Senior Director
Global Regulatory Affairs, Americas                 
ICON Clinical Research
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Michael Anderson, Ph.D.
Director
Global Bioanalytical Operations
ICON Development Solutions

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