FDA Issues Draft Guidance with Updated Recommendations for Assessing the Need for Comparative Efficacy Studies in Biosimilar Development

Last week, FDA released draft guidance titled “Scientific Considerations in Demonstrating Biosimilarity to a Reference Product: Updated Recommendations for Assessing the Need for Comparative Efficacy Studies.” This draft guidance reflects an evolution in FDA’s approach to determining whether a comparative clinical study with efficacy endpoints (a comparative efficacy study or CES) is necessary to support a demonstration of biosimilarity….
By: Akin Gump Strauss Hauer & Feld LLP