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• W4385441812 abstract "ABSTRACTBackground Trastuzumab 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 methods A 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.Results The geometric mean ratios (GMRs) of AUC0-t, Cmax and AUC0-∞ 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.Conclusions Trastuzumab was well tolerated, showed a similar safety profile to its biosimilar, and demonstrated PK equivalence.Clinical trial registration This trial was registered at the [anonymized].KEYWORDS: Breast cancerbioequivalencepharmacokineticssafetytrastuzumab Ethical ApprovalThis trial was approved by the Ethics Committee of [anonymized].AcknowledgmentsThanks to all enrolled participants, investigators, and people who contributed to this study.Author contributions[anonymized]. All authors was substantially contributed to the conception and design of the review article and interpreting the relevant literature, and been involved in writing the review article or revised it for intellectual content.Declaration of interestsAll data related to this study were interpreted by the trial staff with complete independence from the sponsor. [anonymized].The authors have no other relevant affiliations or financial involvement with any organization or entity with financial interest in or financial with the subject matter or materials discussed in the manuscript apart from those disclosed.Availability of data and materialsWe confirm that the figures and tables in the manuscript are original and have not been published before. The data that support the findings of this study are available from the corresponding author upon reasonable request but remain subject to all applicable legal requirements to protect the confidentiality of the study participants’ personal information.Supplementary materialSupplemental data for this article can be accessed online at https://doi.org/10.1080/17425255.2023.2243823Additional informationFundingThis manuscript was supported by [anonymized]." @default.
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• W4385441812 date "2023-08-03" @default.
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• W4385441812 title "A randomized, single-blind, single-dose, parallel-group study in healthy subjects to demonstrate the pharmacokinetic equivalence of trastuzumab and its biosimilar" @default.
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• W4385441812 doi "https://doi.org/10.1080/17425255.2023.2243823" @default.
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