FDA Proposes to Remove Comparative Efficacy Studies to Accelerate Biosimilar Development

With the aim of accelerating approval of biosimilars, the U.S. Food and Drug Administration (“FDA”), in its draft guidance “Scientific Considerations in Demonstrating Biosimilarity to a Reference Product: Updated Recommendations for Assessing the Need for Comparative Efficacy Studies,” proposes relying on comparative analytical assessments in lieu of clinical studies with efficacy endpoints (comparative efficacy studies) to support a demonstration of biosimilarity….
By: Jones Day