A pharmacokinetics phase 1 bioequivalence study of the trastuzumab biosimilar MYL‐1401O <i>vs</i>. EU‐trastuzumab and US‐trastuzumab

Waller, Christiane; Vutikullird, Apinya; Lawrence, Tracey; Shaw, Andrew; Liu, Mark Shiyao; Baczkowski, Mark; Sharma, Rajiv; Barve, Abhijit; Goyal, Parag; Donnelly, Charles; Sengupta, Nilanjan; Pennella, Eduardo J.

doi:10.1111/bcp.13689

Cited by 29 publications

(16 citation statements)

References 22 publications

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“…In this trial, the safety and immunogenicity of SIBP-01 and Herceptin® in PK were similar, which is in accordance with previous studies on trastuzumab [12][13][14]. These data support the continued development of SIBP-01 as a potential drug similar to trastuzumab.…”

Section: Discussionsupporting

confidence: 89%

A randomized Phase I pharmacokinetic trial comparing the potential biosimilar trastuzumab (SIBP-01) with the reference product (Herceptin®) in healthy Chinese male volunteers

Zhou

Cao

Zhu

et al. 2020

Expert Opinion on Drug Metabolism & Toxicology

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Objectives: This study aimed to evaluate the bioequivalence, safety, tolerability and immunogenicity of the biosimilar trastuzumab (SIBP-01) compared to Herceptin®. Methods: In this Phase I randomized double-blind parallel-group trial, 100 healthy male volunteers were randomized in a1:1 ratio to receive a single 6 mg•kg-1 intravenous dose of SIBP-01 or Herceptin®. Serum concentrationswere analyzed using a validated ELISA. Results: The two groups had similar baseline characteristics. The geometric mean ratios (90% CI) of C max , AUC 0-t and AUC inf between the trial group and the reference group were 93.55%-104.27%, 91.98%-102.35% and 91.88%-102.34%, respectively; the geometric mean ratios (90% CI) of AUC 0-t and AUC inf in the sensitivity analysis were 92.29%-102.63% and 91.81%-102.16%, respectively. These values were within the prespecified equivalence margins, establishing the bioequivalence of SIBP-1 and Herceptin®. AEs were similar across all subjects in the SIBP-01 and Herceptin® arms, with treatmentrelated AEs reported by 72.00% and 80.00%, respectively. In each group, there was one AE that caused a subject to discontinue the study. Expert opinion: Trastuzumab (Herceptin®) is significantly more effective than chemotherapy in reducing exacerbations and tumor cell growth, and its adverse events are far lower than chemotherapy. Herceptin®is very expensive for most patients in China. The protein molecular primary structure of the biosimilar trastuzumab (SIBP-01) is consistent with Herceptin®, with highly similar high level structure, biologocal activity and purity.But there are few studies comparing the bioequivalence of SIBP-01 and Herceptin® in healthy subjects and cancer patients. Conclusions: This study showed the PK similarity of SIBP-01 to Herceptin®. SIBP-01 was safe and well tolerated in healthy male volunteers, with no significant differences from the reference drug in safety or immunogenicity.

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Section: Discussionsupporting

confidence: 89%

A randomized Phase I pharmacokinetic trial comparing the potential biosimilar trastuzumab (SIBP-01) with the reference product (Herceptin®) in healthy Chinese male volunteers

Zhou

Cao

Zhu

et al. 2020

Expert Opinion on Drug Metabolism & Toxicology

View full text Add to dashboard Cite

show abstract

“…Approval was, in part, based on the pharmacokinetic bioequivalence between MYL-1401O and trastuzumab, which was established based on similar peak serum concentration, max concentration, half-life, safety, and immunogenicity. 11 In addition, HERITAGE was a double-blind, randomized clinical trial that evaluated equivalence of ORR (defined as within a range of 0.81–1.24) for MYL-1401O compared with trastuzumab when given once every 3 weeks in combination with either paclitaxel or docetaxel for at least 8 cycles as first-line therapy for metastatic breast cancer. The 24 week ORR was 69.6% (CI 90% 64.57–74.56) for MYL-1401O versus 64% (CI 90% 58.81–69.26) in the trastuzumab group (rate ratio 1.09), similarly PFS was at identical in the two groups at 11.1 months.…”

Section: Methodsmentioning

confidence: 99%

Biosimilars for breast cancer: a review of HER2-targeted antibodies in the United States

Miller

Schwartzberg

2019

Ther Adv Med Oncol

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The utilization of trastuzumab biosimilar medications is of particular interest in HER2-positive breast cancer as these drugs have the potential for cost savings and increased utilization/access to HER2 targeted therapy in both early stage and metastatic HER2-positive breast cancers. Five trastuzumab biosimilars: MYL-1401O (Ogivri), CT-P6 (Herzuma), SB3 (Ontruzant), PF-05280014 (Trazimera), and ABP980 (Kanjinti), have now been approved by the US Food and Drug Administration (FDA) for use in HER2-positive breast cancers. This review provides an overview of these agents with special consideration of the development and approval process, including available clinical data results for these trastuzumab biosimilars. Adoption in the clinic will depend on the degree of comfort with the overall evidence.

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“…78 MYL-1401O, another biosimilar of trastuzumab showed excellent tolerability and demonstrated safety characteristics and pharmacokinetics similar to both FDA approved and EU approved trastuzumab in volunteers which were healthy. 79 Trastuzumab is a biologic drug with comparatively high price tag than the traditional therapy and adds a lot to the budget of health care. Trastuzumab/hyaluronidase given subcutaneously famtrastuzumab deruxtecan-nxki and adotrastuzumab emtansine which are 2 of the antibody drug conjugates has widened the treatment alternatives for the related patient community.…”

Section: Trastuzumabmentioning

confidence: 99%

Progress in oncology biosimilars till 2020: Scrutinizing comparative studies of biosimilar monoclonal antibodies

Safdar

Butt

Ahmad

et al. 2021

J Oncol Pharm Pract

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Stupendous elevation in the healthcare costs has followed with the inception of the current unconventional options of treatment available for cancer patients. There is a dire need of innovative financing approaches to lessen the financial load on healthcare system. Biosimilars are biological drugs consisting of an active ingredient from a reference biological drug that has a great potential of relieving financial load. Strict requirements from regulatory point of view are required as biosimilars are exceedingly similar to but not identical to the reference product. This provides with a certainty that no consequential differences from clinical point of view as compared to the respective biologics exists with regards to efficacy, safety and purity. Safety and effectiveness of biosimilars have been disclosed since more than 10 years of affirmations. However, there is a need to educate the healthcare professionals to abolish potential misconceptions and coalesce biosimilars into regular clinical practice. The present review focuses on providing an overview of regulatory aspects and requirements for biosimilars, the main challenges in the selection and development of biosimilars and the economic impact and financial savings observed in recent studies carried out in different parts of the world. In addition, we have discussed the different successful comparative studies which have been done in different parts of the world to depict the biosimilarity for monoclonal antibodies such as bevacizumab, trastuzumab and rituximab.

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

Abstract: MYL-1401O was well tolerated and demonstrated PK and safety profiles similar to EU-trastuzumab and US-trastuzumab in healthy volunteers (ClinicalTrials.gov, NCT02594761).

Cited by 29 publications

References 22 publications

A randomized Phase I pharmacokinetic trial comparing the potential biosimilar trastuzumab (SIBP-01) with the reference product (Herceptin®) in healthy Chinese male volunteers

A randomized Phase I pharmacokinetic trial comparing the potential biosimilar trastuzumab (SIBP-01) with the reference product (Herceptin®) in healthy Chinese male volunteers

Biosimilars for breast cancer: a review of HER2-targeted antibodies in the United States

Progress in oncology biosimilars till 2020: Scrutinizing comparative studies of biosimilar monoclonal antibodies

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