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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| Main Authors: | , , , , |
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| Format: | Article |
| Language: | English |
| Published: |
Taylor & Francis Group
2025-12-01
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| Series: | Annals of Medicine |
| Subjects: | |
| Online Access: | https://www.tandfonline.com/doi/10.1080/07853890.2025.2523561 |
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