EMA Shift To Drop Biosimilar Studies Shows Industry Has ‘Moved The Needle’
Medicines For Europe Responds To Agency Concept Paper On Comparative Efficacy Trials
Responding to a recent EMA concept paper on re-evaluating the need for comparative efficacy studies to support biosimilar applications, Medicines for Europe says the development shows that cumulative experiences with biosimilars have “moved the needle” in terms of regulatory science.
