Biologicals are one of the interesting and effective treatment options which can save the lives of many patients, however, their high cost and restricted access for some patients remains a challenge. The emergence of biosimilars, with their similar efficacy and safety profiles, could be a solution for this hurdle. According to the European Medicines Agency (EMA) guidance entitled ‘Biosimilars in the EU – information guide for healthcare professionals’, a biosimilar is ‘a biological medicine highly similar to another biological medicine already approved in the EU’ . Biosimilars are required to have the same standards of pharmaceutical quality, safety and efficacy as for originator biologicals in order to obtain marketing authorization. Although, according to the EMA guidance ‘approval of biosimilars builds on existing scientific knowledge on safety and efficacy of the reference medicine gained during its clinical use, so fewer clinical data are needed’ .
Trastuzumab is a humanized monoclonal antibody and, as the first-line treatment for breast cancer with overexpression of human epidermal growth factor receptor 2 (HER2), has attracted the attention of biopharmaceutical companies as a promising biosimilar target. Due to the efficacy profile of the trastuzumab reference medicinal product, Herceptin, multiple biosimilars candidates have submitted their non-clinical and clinical data with the aim of obtaining EMA or US Food and Drug Administration (FDA) approval for this product. In fact, several of these biosimilar candidates have already obtained EMA or FDA marketing authorization, including Herzuma, Kanjinti, Ogivri, Ontruzant, Trazimera and Zercepac [3, 4].
AryoTrust, a potential biosimilar candidate of trastuzumab, was manufactured by Iran-based AryoGen Pharmed, one of the leading biopharmaceutical companies in the Middle East and North Africa (MENA) countries. According to the approval pathway for biogenerics in Iran, similarities between AryoTrust and the reference product should be confirmed in stepwise comparability studies. As a result, the similarity of AryoTrust was evaluated by means of quality tests and non-clinical comparability studies, all of which were passed.
In addition, a pharmacokinetics (PK) study, as the first step of clinical trials, was designed and conducted in 60 healthy male subjects in India . This trial was a randomized, double-blind, single-dose, two-arm, parallel study to compare the PK and safety of trastuzumab - namely AryoTrust (trastuzumab) of AryoGen Pharmed, Iran and Herceptin (trastuzumab) of Roche, in healthy male subjects. The primary endpoint of the study was the area under the concentration versus time to infinity (AUC0-inf) and the main secondary endpoints were maximum measured concentration (Cmax), area under the concentration versus time from zero to the last quantifiable concentration time (AUC0-last) and safety of the product, which was in accordance with the EMA guidelines for clinical trials of products administered intravenously.
Sixty healthy male subjects were enrolled in the study with 1:1 ratio for AryoTrust and the reference medicinal product. Results of the study showed a similar PK profile for the two treatment arms and the primary and main secondary endpoints were within the bioequivalence acceptance range (80%–125%) with more than 90% power. In addition, the safety profile of the products was monitored through the study duration and all adverse events reported were mild or moderate and similar between the two treatment groups. Moreover, no serious adverse event or immunogenicity was reported in the study.
Results of the study, which was published in Expert Opinion on Biological Therapy, indicated that the safety profile and bioequivalence of AryoTrust were similar compared to the reference medicinal product, Herceptin .
Readers interested to learn more about clinical trials for trastuzumab biosimilars are invited to visit www.gabi-journal.net to view the following manuscript published in GaBI Journal:
Clinical trials for trastuzumab biosimilars
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1. GaBI Online - Generics and Biosimilars Initiative. EMA biosimilars guidance for healthcare professionals [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Oct 8]. Available from: www.gabionline.net/guidelines/EMA-biosimilars-guidance-for-healthcare-professionals
2. GaBI Online - Generics and Biosimilars Initiative. EU guidelines for biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Oct 8]. Available from: www.gabionline.net/guidelines/EU-guidelines-for-biosimilars
3. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Oct 8]. Available from: www.gabionline.net/biosimilars/general/biosimilars-approved-in-Europe
4. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in the US [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Oct 8]. Available from: www.gabionline.net/biosimilars/general/Biosimilars-approved-in-the-US
5. Farmahini Farahani M, Maghzi P, Jafari Aryan N, et al. A randomized, double-blind, parallel pharmacokinetic study comparing the trastuzumab biosimilar candidate, AryoTrust®, and reference trastuzumab in healthy subjects. Expert Opin Investig Drugs. 2020;29(12):1443-50.
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