Scientific Considerations in Demonstrating Biosimilarity to a Reference Product: Updated Recommendations for Assessing the Need for Comparative Efficacy Studies Draft Guidance for Industry October 2025

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/scientific-considerations-demonstrating-biosimilarity-reference-product-updated-recommendations?utm_medium=email&utm_source=govdelivery FDA Moves to Accelerate Biosimilar Development and Lower Drug Costs https://www.fda.gov/news-events/press-announcements/fda-moves-accelerate-biosimilar-development-and-lower-drug-costs?utm_medium=email&utm_source=govdelivery FDA Issues Draft Guidance to Industry, “Scientific Considerations in Demonstrating Biosimilarity to a Reference Product: Updated Recommendations for Assessing the Need for Comparative Efficacy Studies” Today, FDA released a draft guidance for industry “Scientific Considerations in Demonstrating Biosimilarity to a Reference Product: Updated Recommendations for Assessing the Need for Comparative Efficacy Studies.” This draft guidance describes updated scientific considerations regarding a comparative clinical study with efficacy endpoints (comparative efficacy study or CES) intended to support a demonstration of biosimilarity. Since publication of the Scientific Considerations Guidance in April 2015, FDA has gained significant experience in evaluating analytical differences between proposed biosimilar products and reference products and understanding their impact on clinical performance. As experience with the development and approval of biosimilars has grown, there has been increasing recognition that CES are not as sensitive as modern analytical technologies for detecting differences between products. Accordingly, FDA’s scientific approach to when a CES may be needed to support a demonstration of biosimilarity is evolving. The draft guidance provides an overview of important scientific considerations for determining when a CES may inform a demonstration of biosimilarity. FDA is issuing this draft guidance to seek public comment through the accompanying docket (Docket No. FDA-2011-D-0605). Visit Regulations.gov for instructions on how to comment. This draft guidance describes scientific considerations that support a streamlined approach to demonstrating biosimilarity, which should reduce the time and cost of biosimilar development and help increase access to medications for American patients.