FDA Biosimilars Draft Guidance - Scientific Considerations in Demonstrating Biosimilarity to a Reference Product

• By: www.fda.gov
• Date: March 15, 2012

On February 9, 2012, the U.S FDA released draft guidelines about scientific and quality considerations in bio-similar product development. These guidelines provide insight into the procedures which are required to show high similarity with an FDA-licensed biological product and provide an overview of FDA’s approach in determining bio-similarity of a biologic product.

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