A randomized, double-blind, parallel pharmacokinetic study comparing the trastuzumab biosimilar candidate, AryoTrust®, and reference trastuzumab in healthy subjects

Farahani, Mohammad Farmahini; Maghzi, Parnian; Aryan, Nazanin Jafari; Payandemehr, Borna; Soni, Mayur; Azhdarzadeh, Morteza

doi:10.1080/13543784.2020.1831470

Cited by 9 publications

(8 citation statements)

References 18 publications

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“…Biosimilar refers to biological products containing the approved active substances of the original biological drugs (Zhang et al, 2020a;Zhang et al, 2020b). The emergence of biosimilars can provide more advanced treatment options for larger numbers of patients (Bushra et al, 2020;Farahani et al, 2020). At the same time, it can also reduce the cost of health care (Zhang et al, 2020a;Farahani et al, 2020).…”

Section: Introductionmentioning

confidence: 99%

“…The emergence of biosimilars can provide more advanced treatment options for larger numbers of patients (Bushra et al, 2020;Farahani et al, 2020). At the same time, it can also reduce the cost of health care (Zhang et al, 2020a;Farahani et al, 2020). The production process of biological agents is complex, and any slight difference may cause the final product to fail (Zhang et al, 2020a;Zhang et al, 2020b).…”

Section: Introductionmentioning

confidence: 99%

“…The production process of biological agents is complex, and any slight difference may cause the final product to fail (Zhang et al, 2020a;Zhang et al, 2020b). Therefore, biosimilars should be comparable with reference preparations in terms of quality, biological activity, safety and efficacy to ensure their safety and effectiveness before they can be approved for marketing (Zhang et al, 2020a;Farahani et al, 2020;Finck et al, 2020;Zhu et al, 2020). It is very important to study the pharmacokinetics (PK), efficacy, safety and immunogenicity of biosimilars (Shin et al, 2020).…”

Section: Introductionmentioning

confidence: 99%

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Pharmacokinetics, Immunogenicity and Safety Study for SHR-1309 Injection and Perjeta® in Healthy Chinese Male Volunteers

Cui

Ren

et al. 2021

Front. Pharmacol.

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Objectives: Pertuzumab is a monoclonal antibody for the treatment of breast cancer. The aim of this study was to compare the pharmacokinetics, immunogenicity and safety of the test preparation SHR-1309 injecta and the reference preparation Perjeta® in healthy Chinese male subjects.Methods: In this randomized, double-blind, single dose, two-way, parallel bioequivalence trial, a total of 80 qualified Chinese male subjects were selected and randomly divided into two groups. Each subject was intravenously injected with SHR-1309 or Perjeta®. Blood samples were collected at 21 different time points for pharmacokinetic analysis. In addition, immunogenicity was assessed at five different time points. The safety of the medication was monitored throughout the whole trial.Results: Cmax and AUC0-t were the primary pharmacokinetic parameters. Under a 90% confidence interval, their geometric mean ratios were 98.30 and 88.41% for SHR-1309 injection and Perjeta®, respectively. The geometric mean ratio of secondary pharmacokinetic parameters AUC0-∞ was 88.58%. These evaluation indexes are in the standard range of 80–125%, so SHR-1309 can be considered bioequivalent to Perjeta®. After 1,680 h (day 70) of administration, the two groups had 12 and 13 subjects who produced antidrug antibody (ADA), respectively. The occurrence time and proportion of ADA in SHR-1309 and Perjeta® were similar between subjects, and they had similar immunogenicity. During the entire trial period, there were 71 drug-related adverse reactions in 29 subjects who received SHR-1309 and 61 drug-related adverse reactions in 32 subjects who received Perjeta®. The incidence of adverse reactions between the two drugs was similar.Conclusion: The pharmacokinetic parameters, immunogenicity and safety of the biosimilar SHR-1309 injection produced by Shanghai Hengrui Pharmaceutical Co. Ltd. were similar to the original drug Perjeta® produced by Roche Pharma AG. The two drugs met the bioequivalence evaluation criteria. Therefore, SHR-1309 is bioequivalent to Perjeta®. Clinical trial registration: CTR20200,738.

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Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Pharmacokinetics, Immunogenicity and Safety Study for SHR-1309 Injection and Perjeta® in Healthy Chinese Male Volunteers

Cui

Ren

et al. 2021

Front. Pharmacol.

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“…No serious adverse reactions or immunogenicity were reported. All of the side effects reported were mild and similar between the two treatment groups [ 53 ].…”

Section: Resultsmentioning

confidence: 99%

Systematic Review on the Use of Biosimilars of Trastuzumab in HER2+ Breast Cancer

Triantafyllidi

Triantafillidis

2022

Biomedicines

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Trastuzumab is a monoclonal antibody used in the treatment of breast cancer in cases where the tumor overexpresses the HER2 receptor, a cell membrane receptor activated by the epidermal growth factor. Intravenous and subcutaneous administration of trastuzumab have comparable clinical and pharmacological characteristics, but trastuzumab biosimilars are currently only available in intravenous form. Trastuzumab biosimilars are ultimately preferred by a proportion of patients, especially in cases where co-administration of other chemotherapeutic agents, such as trastuzumab and tucatinib, a small molecule of tyrosine kinase inhibitor, is required in patients with HER-positive metastatic breast cancer. Oncologists should be well-aware of the advantages of intravenously administered trastuzumab biosimilars over subcutaneous administration, certainly also taking into account the patient’s preferences. Further cost-effectiveness analyses will be very important, along with expectations regarding successful concomitant subcutaneous administration of trastuzumab with other anticancer drugs, such as pertuzumab. This systematic review describes and analyzes the so-far published studies concerning the use of the available trastuzumab biosimilars in HER-positive early and metastatic breast cancer in terms of efficacy, safety, and cost–benefit ratio. An attempt was also made to draw some conclusions and to comment on future needs and perspectives.

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“…This is consistent with previous studies, and these data support the continued development of the test drug as a biological drug candidate similar to the reference drug (Table S4). 11‐20 …”

Section: Discussionmentioning

confidence: 99%

A Randomized, Single‐dose, Phase I Clinical Comparison of a Trastuzumab Biosimilar With a Reference Trastuzumab Formulation in Healthy Chinese Male Volunteers

Jia

Zhao

et al. 2022

Clinical Pharm in Drug Dev

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The test drug, a recombinant humanized monoclonal antibody, is a biosimilar candidate for the reference drug. The purpose of this study was to evaluate the bioequivalence of these two drugs. The study was divided into two parts, a pre‐study and a formal trial. The pre‐study included two subjects who were each given a single intravenous infusion of 6 mg/kg test drug. The formal trial was designed to be a randomized, double‐blind, parallel controlled trial in which 70 subjects were randomly assigned 1:1 to receive either test or reference drug as a single 6 mg/kg intravenous infusion. In the pre‐study, the immunogenicity was negative in both subjects and the safety of the test drug was considered to be good. The two groups in the formal trial had similar demographic characteristics. The 90% confidence interval of geometric mean ratios of area under the serum concentration‐time curve from the time 0 to the time of last quantifiable concentration, area under the serum concentration‐curve from time 0 to infinity, and maximum observed serum concentration between the test group and the reference group fell between 80% and 125% and the bioequivalence was recognized. There was no significant difference in the positive rate of antidrug antibodies. The treatment‐emergent adverse events in the test group were similar to those in the reference group. This study showed that the test drug has similar pharmacokinetics, immunogenicity, and safety to the reference drug in healthy male subjects.

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A randomized, double-blind, parallel pharmacokinetic study comparing the trastuzumab biosimilar candidate, AryoTrust®, and reference trastuzumab in healthy subjects

Cited by 9 publications

References 18 publications

Pharmacokinetics, Immunogenicity and Safety Study for SHR-1309 Injection and Perjeta® in Healthy Chinese Male Volunteers

Pharmacokinetics, Immunogenicity and Safety Study for SHR-1309 Injection and Perjeta® in Healthy Chinese Male Volunteers

Systematic Review on the Use of Biosimilars of Trastuzumab in HER2+ Breast Cancer

A Randomized, Single‐dose, Phase I Clinical Comparison of a Trastuzumab Biosimilar With a Reference Trastuzumab Formulation in Healthy Chinese Male Volunteers

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