Scientific Justification and Policy Recommendations to the US Food and Drug Administration for Waiving Comparative Efficacy Studies

Scientific Justification and Policy Recommendations to the US Food and Drug Administration for Waiving Comparative Efficacy Studies

This detailed review looks at how the rules for proving biosimilarity are changing, mainly focusing on the requirements for comparative efficacy studies (CESs). As analytical technologies progress, mounting evidence suggests that when we establish robust analytical similarity and pharmacokinetic equ...

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Bibliographic Details
Main Author: Sarfaraz K. Niazi
Format: Article
Language:English
Published: MDPI AG 2025-05-01
Series:Pharmaceuticals
Subjects:
biosimilars
BPCIA
FDA
EMA
MHRA
clinical efficacy study
Online Access:https://www.mdpi.com/1424-8247/18/6/779
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