Implementation of the Anchor-Based Indirect Comparison Method for Equivalence Margin Derivation in Biosimilar Development

Implementation of the Anchor-Based Indirect Comparison Method for Equivalence Margin Derivation in Biosimilar Development

<b>Background/Objectives</b>: To derive the equivalence margin (EQM), typically, a “classical” meta-analysis on direct within-trial estimation of the effect size of the reference drug compared to the placebo or standard of care is performed: a certain factor of the 95% confidence interva...

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Bibliographic Details
Main Authors: Claudia Hemmelmann, Rachid El Galta, Jessie Wang, Susanne Schmitt, Ramin Arani
Format: Article
Language:English
Published: MDPI AG 2025-02-01
Series:Pharmaceuticals
Subjects:
biosimilarity
equivalence margin
indirect approach
network meta-analysis
Online Access:https://www.mdpi.com/1424-8247/18/3/285
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