Post-marketing Surveillance for Evaluation of AryoTrust Safety in Iranian HER2-positive Breast Cancer Patients Undergoing Adjuvant Chemotherapy Regimens

This study was a phase IV, observational, multicenter, single-arm, open-label, post-marketing surveillance study for the assessment of AryoTrust safety in Iranian HER2-positive breast cancer patients undergoing adjuvant chemotherapy regimens.

Start Date22 Feb 2017

Sponsor / Collaborator

Aryogen Pharmed

IRCT201208116302N4 / CompletedPhase 3IIT

Double blind? Randomized clinical trial of the efficacy of Aryogen Trastuzumab compared to Genentech/roche Trastuzumab in breast cancer

Start Date21 Apr 2013

Sponsor / Collaborator

Aryogen Biopharma

100 Clinical Results associated with Trastuzumab biosimilar(Aryogen)

100 Translational Medicine associated with Trastuzumab biosimilar(Aryogen)

100 Patents (Medical) associated with Trastuzumab biosimilar(Aryogen)

Literatures (Medical) associated with Trastuzumab biosimilar(Aryogen)

01 Jan 2023·Supportive Care in Cancer

Availability and affordability of anticancer medicines in Iran based on WHO/HAI standard survey methods

Article

Author: Sarafraz, Shirin ; Ghavami, Vahid ; Mojahedian, Mohammad M ; Varmaghani, Mehdi ; Borhani, Behnam ; Elyasi, Sepideh ; Javan-Noughabi, Javad

PURPOSECancer is the second leading cause of death in the world after cardiovascular disease. The present study aimed to investigate the affordability and physical access to chemotherapy drugs among patients with one of the three common cancers of the breast, stomach, and colon in the city of Mashhad, Iran, in 2021.METHODSThis was a descriptive cross-sectional study. Twenty drug stores including two public and 18 privates in Mashhad were evaluated. Data was collected by consistent stay in the drug stores or pharmacies. For each oncology medicine, selling price, lowest general price, and availability were investigated. Three approaches have been experimented to calculate the affordability of anticancer medicines in this study.RESULTSOut of 28 studied medicines from public and private drug stores, 15 (53.5%) received very low, 8 (28.5%) relatively high, and 2 (7%) high access scores. The generic docetaxel brand's ultra-drug and trastuzumab (AryoTrust) were the most available drugs, but the doxorubicin (Ebewe), oxaliplatin (Mylan), and trastuzumab (Herceptin) were not available to the individuals with cancer. Also, the first approach (based on income decile) indicated that insured patients from all income deciles were able to pay the costs of the lowest price drugs of the DCF drug regimen, and if the patients were insured and belonged to the ninth income decile, they had the financial ability to buy drugs at the lowest price of the FLO drug regimen.CONCLUSIONUnaffordability of cancer medicines can lead to treatment abandonment and increase inequality in access to healthcare services. Therefore, this requires immediate attention of policy makers to be planned in order to ensure to reducing the costs of medicines for patients and increasing patient access to anticancer medicines.

01 Dec 2020·Expert Opinion on Investigational DrugsQ2 · MEDICINE

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

Q2 · MEDICINE

Article

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

BACKGROUNDAryoTrust® (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 METHODSIn 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 (AUC_0-inf), and the main secondary endpoints were maximum measured concentration (C_max), area under the concentration versus time from zero to the last quantifiable concentration time (AUC_0-last), immunogenicity, and safety.RESULTSSixty 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.CONCLUSIONAryoTrust® was well tolerated, had a similar safety profile to reference trastuzumab, and its pharmacokinetic bioequivalence was confirmed.TRIAL REGISTRATIONThe trial is registered at Indian Trials Registry (CTRI/2019/03/018218).

100 Deals associated with Trastuzumab biosimilar(Aryogen)

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KEGG	Wiki	ATC	Drug Bank
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R&D Status

Approved

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Indication	Country/Location	Organization	Date
Breast Cancer	-	Aryogen Pharmed	-
Stomach Cancer	-	Aryogen Pharmed	-

Developing

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Indication	Highest Phase	Country/Location	Organization	Date
HER2 Positive Breast Cancer	Phase 2	IR	Aryogen Pharmed	22 Feb 2017

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