A phase I, randomized, double-blind, parallel, single-dose pharmacokinetic study to evaluate the biosimilarity of KM118 (proposed pertuzumab biosimilar) with reference pertuzumab (Perjeta®) in healthy male subjects

Objective KM118 is a biosimilar to pertuzumab (Perjeta®). This study aimed to prove the pharmacokinetics (PK) biosimilarity and evaluate the safety, tolerability, and immunogenicity of KM118 and the original drug Perjeta® so that it can be approved for the marketing of biosimilar drugs in China.Meth...

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Bibliographic Details
Main Authors: Yan Li, Yu Wang, Caixia Yang, Na Zhao, Xinghe Wang
Format: Article
Language:English
Published: Taylor & Francis Group 2025-12-01
Series:Annals of Medicine
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Online Access:https://www.tandfonline.com/doi/10.1080/07853890.2025.2523561
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