A randomized, single-blind, single-dose, parallel-group study in healthy subjects to demonstrate the pharmacokinetic equivalence of trastuzumab and its biosimilar

BackgroundTrastuzumab is a humanized anti-HER2 monoclonal antibody used in the treatment of breast cancer. This study compared the pharmacokinetics (PK), immunogenicity and safety of trastuzumab (Roche Pharma AG) and its biosimilar (Chia Tai Tianqing Pharmaceutical Group Co. Ltd) in healthy Chinese subjects.Research design and methodsA randomized, parallel, double-blind, single-dose study was conducted. Healthy male subjects were randomized to receive trastuzumab (n = 43) or its biosimilar (n = 43) intravenously at a dose of 4 mg. Plasma drug concentrations were detected by enzyme-linked immunosorbent assay (ELISA), and PK parameters were statistically analyzed. Safety and immunogenicity were also evaluated.ResultsThe geometric mean ratios (GMRs) of AUC(0-t), C-max and AUC(0-& INFIN;) for trastuzumab and its biosimilar were 92.3%, 100.77% and 92.2%, respectively. The 90% CIs were all within 80%-125%, meeting the bioequivalence standards. No serious adverse events or immunogenicity were reported, and all the adverse events reported were mild and similar between the two treatment groups.ConclusionsTrastuzumab was well tolerated, showed a similar safety profile to its biosimilar, and demonstrated PK equivalence.