Pharmacokinetic equivalence of CT‐P39 and reference omalizumab in healthy individuals: A randomised, double‐blind, parallel‐group, Phase 1 trial

Pharmacokinetic equivalence of CT‐P39 and reference omalizumab in healthy individuals: A randomised, double‐blind, parallel‐group, Phase 1 trial

Abstract Background CT‐P39 is being developed as a biosimilar of reference omalizumab. This study aimed to assess the pharmacokinetic equivalence of CT‐P39 to European Union‐approved and United States‐licensed reference omalizumab (EU‐ and US‐omalizumab, respectively). Methods This two‐part, randomi...

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Bibliographic Details
Main Authors: Marcus Maurer, Sarbjit S. Saini, Kristi McLendon, Paul Wabnitz, Sunghyun Kim, Keumyoung Ahn, Suyoung Kim, Sewon Lee, Clive Grattan
Format: Article
Language:English
Published: Wiley 2022-11-01
Series:Clinical and Translational Allergy
Subjects:
biosimilar
CT‐P39
immunoglobulin E
omalizumab
pharmacokinetics
Online Access:https://doi.org/10.1002/clt2.12204

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