FDA (CDER)
GUIDANCE DRAFT
Scientific Considerations in Demonstrating Biosimilarity to a Reference Product: Updated Recommendations for Assessing the Need for Comparative Efficacy Studies: Draft Guidance for Industry
Published: 10/29/2025Detected: 3/20/2026
Summary preview
Clarifies FDA’s scientific approach for assessing biosimilarity when comparative efficacy studies may or may not be needed, helping sponsors justify a biosimilar development plan without always conducting additional…
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