Factors to be Considered in Bio-Similar Product Development – Overview of FDA Draft Guidance

• By: Staff Editor
• Date: March 16, 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.