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Biosimilarity to a Reference Product: Updated Recommendations for Assessing the Need for Comparative Efficacy Studies: Draft Guidance for Industry

Issue Date: October 29, 2025
Issued by: Center for Drug Evaluation and Research,Office of New Drugs,Office of Therapeutic Biologics and Biosimilars
Topic(s): Biosimilars
Status: Draft

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Biosimilarity to a Reference Product: Updated Recommendations for Assessing the Need for Comparative Efficacy Studies: Draft Guidance for Industry

This draft guidance describes considerations regarding a comparative clinical study or studies with efficacy endpoints (a comparative efficacy study or CES) intended to support a demonstration that a proposed therapeutic protein product is biosimilar to a reference product for the purpose of submitting a marketing application under the Public Health Service Act (PHS Act).

Download the Guidance Document