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ORIGINAL RESEARCH ARTICLE

Preclinical evaluation reveals comparable toxicology and pharmacology of the erythropoietin biosimilar GBpoietin® and Eprex®

Kakon Nag1,2* ,  Mohammad Mohiuddin1 ,  Md. Maksudur Rahman Khan1 ,  Samir Kumar1 ,  Md. Enamul Haq Sarker1 ,  Bipul Kumar Biswas1 ,  Sheikh Rejaul Haq1 ,  Sitesh Chandra Bachar3* ,  Naznin Sultana1,2*
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1 Globe Biotech Limited, Dhaka, Bangladesh
2 R&D Management Solution Inc., Ontario, Canada
3 Department of Pharmacy, Faculty of Pharmacy, University of Dhaka, Dhaka, Bangladesh
INNOSC Theranostics and Pharmacological Sciences, 5797 https://doi.org/10.36922/itps.5797
Submitted: 6 November 2024 | Revised: 9 January 2025 | Accepted: 5 February 2025 | Published: 26 February 2025
© 2025 by the Author(s). This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution 4.0 International License ( https://creativecommons.org/licenses/by/4.0/ )
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Abstract

Erythropoietin (EPO) is an essential growth factor for erythropoiesis. We report the results of the preclinical safety evaluation of GBpoietin®, a recombinant human EPO (rhEPO), through a comparative acute toxicity study with the reference product, Eprex®. The products were administered subcutaneously into Wistar rats for both the single-dose and repeated-dose toxicity studies. Hematological and biochemical parameters were measured for all test subjects before the first dose and the day after the last dose in both studies. Necropsy and histopathology of representative subjects from each group were also performed to find any pathological changes, such as degeneration or cellular necrosis in internal organs such as the kidney, liver, lung, and spleen. Both GBpoietin® and Eprex® comparative toxicology studies, which were not significantly different (P > 0.05), revealed similar pharmacologically driven mechanisms of toxicity. Although hematological parameters stayed within the normal range throughout the study, improved profiles of hemoglobin and hematocrit (P < 0.05) confirmed the therapeutic effect of rhEPO in both studies. Moreover, the initial and final values of aspartate aminotransferase, alanine aminotransferase, and blood urea nitrogen were comparable (P > 0.05) for both experimental products. The study established that the toxicological profiles of GBpoietin® and Eprex® were similar and aligned with the known pharmacology of EPO alfa, demonstrating proof of “totality” and “no residual uncertainty.”

Keywords
Erythropoietin
Preclinical study
Single-dose toxicity
Repeat-dose toxicity
GBpoietin®
Drug safety profile
Funding
The study was funded by Globe Biotech Limited.
Conflict of interest
Kakon Nag is the CEO of Globe Biotech Limited, Dhaka, Bangladesh and R&D Management Solution Inc., Ontario, Canada. However, this has not influenced the content of the manuscript. The other authors declare that they have no competing interests.
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INNOSC Theranostics and Pharmacological Sciences, Electronic ISSN: 2705-0823 Print ISSN: 2705-0734, Published by AccScience Publishing
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