A randomized, double-blind, parallel pharmacokinetic study comparing the trastuzumab biosimilar candidate, AryoTrust®, and reference trastuzumab in healthy subjects. (1st December 2020)

• Record Type: Journal Article
• Authors: Farmahini Farahani, Mohammad; Maghzi, Parnian; Jafari Aryan, Nazanin; Payandemehr, Borna; Soni, Mayur; Azhdarzadeh, Morteza
• Is Part Of: Expert opinion on investigational drugs. Volume 29:Number 12(2020)
• Page Start: 1443
• Page End: 1450
• Publication Date: 2020-12-01
• Subjects: Bioequivalence -- biosimilar -- breast cancer -- drug Safety -- pharmacokinetics; Drugs -- Design -- Periodicals; Drugs, Investigational -- Bibliography; Drugs, Investigational -- Periodicals; 615.1
• DOI: 10.1080/13543784.2020.1831470
• Languages: English
• ISSNs: 1354-3784

Abstract

ABSTRACT: Background: AryoTrust® (AryoGen Pharmed Co., Iran) is a biosimilar candidate for the EU-sourced reference trastuzumab, Herceptin®. This study was designed to evaluate the bioequivalence between AryoTrust® and Herceptin®. Research design and methods: In this double-blind, parallel study, 60 healthy male subjects were randomized 1:1 to receive a single dose of AryoTrust® or Herceptin® (6 mg/kg) as intravenous infusion. The primary endpoint of the study was the area under the concentration versus time to infinity (AUC0-inf ), and the main secondary endpoints were maximum measured concentration (Cmax ), area under the concentration versus time from zero to the last quantifiable concentration time (AUC0-last ), immunogenicity, and safety. Results: Sixty subjects were enrolled in the study and baseline demographics were similar between the two groups. The two groups demonstrated similar pharmacokinetic parameters and the 90% confidence interval (CI) for primary and secondary endpoints were within the bioequivalence acceptance range (80.00%–125.00%). No serious adverse event or immunogenicity was reported, and all of the adverse events reported were mild and similar between the two treatment groups. Conclusion: AryoTrust® was well tolerated, had a similar safety profile to reference trastuzumab, and its pharmacokinetic bioequivalence was confirmed. Trial registration: The trial is registered at Indian Trials Registry (CTRI/2019/03/018218)