Quality Considerations for Demonstrating Bio-similarity to Reference Product – What Does FDA Draft Guidance Say?

• By: Staff Editor
• Date: March 23, 2012

On February 9, 2012, the FDA released draft guidelines about 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 are based on key scientific and regulatory factors which should be considered for submission of applications for bio-similar products to the FDA.