TROIKA‐1: A double‐blind, randomized, parallel group, study aimed to demonstrate the equivalent pharmacokinetic profile of HD201, a potential biosimilar candidate to trastuzumab, versus EU‐Herceptin® and US‐Herceptin® in healthy male subjects

TROIKA‐1: A double‐blind, randomized, parallel group, study aimed to demonstrate the equivalent pharmacokinetic profile of HD201, a potential biosimilar candidate to trastuzumab, versus EU‐Herceptin® and US‐Herceptin® in healthy male subjects

Abstract Prestige Biopharma Ltd (Singapore) has developed HD201, a proposed biosimilar to reference product trastuzumab. As a part of the stepwise approach to ensure comparability between the biosimilar candidate and the reference medicinal product, a phase I study in healthy subjects was conducted...

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Bibliographic Details
Main Authors: Martin Demarchi, Pierre Coliat, Kristi Mclendon, Jocelyn Chung Shii Hii, Peggy Feyaerts, Felicia Ang, Litha Jaison, Filip Deforce, Marie Paule Derde, Michael Jinwoo Kim, Lisa Soyeon Park, Alexandre Detappe, Xavier Pivot
Format: Article
Language:English
Published: Wiley 2021-08-01
Series:Pharmacology Research & Perspectives
Subjects:
biosimilar
pharmacokinetic
trastuzumab
Online Access:https://doi.org/10.1002/prp2.839

Internet

https://doi.org/10.1002/prp2.839

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