Draft Guidance Updated on Demonstrating Biosimilarity to Accelerate Development; Provides New Framework Where Comparative Efficacy Studies are not Needed
October 29, 2025 | |
Draft Guidance Updated on Demonstrating Biosimilarity to Accelerate Development; Provides New Framework Where Comparative Efficacy Studies are not Needed
The Food and Drug Administration (FDA) released new draft guidance to accelerate development of biosimilars by addressing the necessity of comparative efficacy studies (press release, fact sheet). This action is pursuant to President Trump’s executive order titled Lowering Drug Prices by Once Again Putting Americans First. Additional details follow. Current State of Biosimilars – In the fact sheet, HHS details… (Slifer, October 29, 2025) #Biosimilars, #Food and Drug Administration, #Prescription Drugs
