FDA Moves to Accelerate Biosimilar Development and Lower Drug Costs in New Draft Guidance

On October 29, 2025, the FDA released a new draft guidance “Scientific Considerations in Demonstrating Biosimilarity to a Reference Product: Updated Recommendations for Assessing the Need for Comparative Efficacy Studies” designed to accelerate the development of biosimilars and reduce drug costs by simplifying the testing process and removing unnecessary clinical study requirements….
By: Venable LLP