A Phase I Clinical Study Comparing the Tolerance, Immunogenicity, and Pharmacokinetics of Proposed Biosimilar BAT1806 and Reference Tocilizumab in Healthy Chinese Men

A Phase I Clinical Study Comparing the Tolerance, Immunogenicity, and Pharmacokinetics of Proposed Biosimilar BAT1806 and Reference Tocilizumab in Healthy Chinese Men

Objective: The study aimed to explore the bioequivalence of a proposed biosimilar BAT1806 to its reference products marketed in the EU and US (RoActemra-EU and Actemra-US) among healthy Chinese men. The tolerance, immunogenicity, and pharmacokinetics (PK) of the three drugs were also investigated.Me...

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Bibliographic Details
Main Authors: Hong Zhang, Hong Wang, Haijing Wei, Hong Chen, Jingrui Liu, Cuiyun Li, Xiaoxue Zhu, Xiaojiao Li, Jinchen Yu, Yinbo Zhou, Xiaolei Yang, Zhaohe Wang, Min Wu, Yanhua Ding
Format: Article
Language:English
Published: Frontiers Media S.A. 2021-01-01
Series:Frontiers in Pharmacology
Subjects:
tocilizumab
biosimilar
immunogenicity
pharmacokinetics
intersubject variability tolerance
variability
Online Access:https://www.frontiersin.org/articles/10.3389/fphar.2020.609522/full

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https://www.frontiersin.org/articles/10.3389/fphar.2020.609522/full

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