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A. Mishra

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Open access Sep 2026

Efficacy and Safety of EG12014 (Biosimilar Trastuzumab) Compared to Reference Trastuzumab in HER2-Positive Early Breast Cancer: A Phase III Randomized Study.

INTRODUCTION Trastuzumab biosimilar EG12014 (Herwenda®; EirGenix/Sandoz) was approved by the European Medicines Agency (EMA) in 2023. We aim to demonstrate equivalent efficacy, and to compare safety, immunogenicity, and pharmacokinetic (PK) profiles, of EG12014 and reference trastuzumab (ref-TRA) in early breast cancer...

Chiun-Sheng Huang, G. Dzagnidze, B. Grohmann-Izay et al. · 0 citations

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