MYL-0140 is bioequivalent to both EU-trastuzumab and US-trastuzumab in healthy subjects

Article title: A pharmacokinetics phase 1 bioequivalence study of the trastuzumab biosimilar MYL‐1401O vs. EU‐trastuzumab and US‐trastuzumab

Citation: Waller CF et al. Br J Clin Pharmacol 2018;84:2336–43

Publication date: October 2018

Trastuzumab is a humanised monoclonal antibody that binds to HER2 and effectively fights breast cancer cells overexpressing this oncoprotein. This study looked at the pharmacokinetics of a novel biosimilar version of trastuzumab and aimed to confirm its bioequivalence with both EU- and US-sourced originator biologics.

Monoclonal antibody (mAb) biologics that target the host immune response or modify specific intracellular pathways have been successfully established for the treatment or palliation of many different cancers. Trastuzumab is a mAb directed against HER2, an oncoprotein overexpressed in some patients with breast and gastric cancers. MYL-0140 is the first FDA-approved trastuzumab biosimilar. In this phase I bioequivalence study, its pharmacokinetics profile was compared with those of both EU- and US-sourced trastuzumab (i.e., EU-trastuzumab and US-trastuzumab).

Healthy male subjects were randomized to take a single infusion of MYL-0140, EU-trastuzumab, or US-trastuzumab. Blood samples were collected regularly over the first 48 hours post-infusion and at approximately 1–2-week intervals thereafter for up to 10 weeks. Treatment-emergent adverse events (TEAEs) were monitored throughout the study.


Serum trastuzumab concentration–time curve was similar across all three treatment groups. All pharmacokinetic parameters (peak serum concentrations and the area under the curve values) across the groups were within the pre-defined bioequivalence interval. All TEAEs were mild or moderate in severity, and the number of subjects with antidrug antibodies (ADAs) was comparable among the groups.

This study demonstrates bioequivalence between single-dose MYL-0140, EU-trastuzumab, and US-trastuzumab administered to healthy subjects. All three drugs had similar safety profiles and there was no evidence of immunogenicity.

Key takeaway

Trastuzumab is a monoclonal antibody directed against HER2-overexpressing cancers. This phase I bioequivalence study demonstrated bioequivalence between single-dose MYL-0140, EU-trastuzumab, and US-trastuzumab administered to healthy subjects.

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