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USFDA’s Draft Guidance: Scientific Considerations in Demonstrating Biosimilarity to a Reference Product
The U.S. Food and Drug Administration (FDA) has released a new draft guidance titled “ Scientific Considerations in Demonstrating Biosimilarity to a Reference Product: Updated Recommendations for Assessing the Need for Comparative Efficacy Studies ” (October 2025). This document represents a major shift in the FDA’s scientific and regulatory approach to biosimilar product development, particularly regarding when comparative efficacy studies (CES) may or may not be required
Sharan Murugan
Nov 1, 20252 min read
USFDA Guidance: Interchangeability: Considerations in Demonstrating Interchangeability With a Reference Product
The USFDA's updated guidance (21 June, 2024) on "Considerations in Demonstrating Interchangeability With a Reference Product" provides...
Sharan Murugan
Jun 22, 20242 min read