Page 61 - ITPS-8-2

INNOSC Theranostics

and Pharmacological Sciences

ORIGINAL RESEARCH ARTICLE
Preclinical evaluation reveals comparable

toxicology and pharmacology of the
erythropoietin biosimilar GBpoietin and Eprex ®
®

Kakon Nag * , Mohammad Mohiuddin 1 , Md. Maksudur Rahman Khan 1 ,
1,2
Samir Kumar 1 , Md. Enamul Haq Sarker 1 , Bipul Kumar Biswas 1 ,
Sheikh Rejaul Haq 1 , Sitesh Chandra Bachar * , and Naznin Sultana *
1,2
3
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

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
®
*Corresponding authors: (rhEPO), through a comparative acute toxicity study with the reference product,
Kakon Nag Eprex . The products were administered subcutaneously into Wistar rats for both
®
(kakonpoly@yahoo.com)
Sitesh Chandra Bachar the single-dose and repeated-dose toxicity studies. Hematological and biochemical
(bacharsc63@gmail.com) parameters were measured for all test subjects before the first dose and the day
Naznin Sultana after the last dose in both studies. Necropsy and histopathology of representative
(kakonpoly@gmail.com)
subjects from each group were also performed to find any pathological changes,
Citation: Nag K, Mohiuddin M, such as degeneration or cellular necrosis in internal organs such as the kidney, liver,
Khan MMR, et al. Preclinical ® ®
evaluation reveals comparable lung, and spleen. Both GBpoietin and Eprex comparative toxicology studies, which
toxicology and pharmacology of the were not significantly different (P > 0.05), revealed similar pharmacologically driven
®
erythropoietin biosimilar GBpoietin mechanisms of toxicity. Although hematological parameters stayed within the
and Eprex . INNOSC Theranostics
®
and Pharmacological Sciences. normal range throughout the study, improved profiles of hemoglobin and hematocrit
2025;8(2):55-67. (P < 0.05) confirmed the therapeutic effect of rhEPO in both studies. Moreover, the
doi: 10.36922/itps.5797 initial and final values of aspartate aminotransferase, alanine aminotransferase, and
Received: November 6, 2024 blood urea nitrogen were comparable (P > 0.05) for both experimental products.
The study established that the toxicological profiles of GBpoietin and Eprex were
®
®
Revised: January 9, 2025
similar and aligned with the known pharmacology of EPO alfa, demonstrating proof
Accepted: February 5, 2025 of “totality” and “no residual uncertainty.”
Published online: February 26,
2025
Keywords: Erythropoietin; Preclinical study; Single-dose toxicity; Repeat-dose toxicity;
Copyright: © 2025 Author(s). GBpoietin ; Drug safety profile
®
This is an Open-Access article
distributed under the terms of the
Creative Commons Attribution
License, permitting distribution,
and reproduction in any medium, 1. Introduction
provided the original work is
properly cited. The hormone erythropoietin (EPO), a glycoprotein, is essential for the production of
Publisher’s Note: AccScience red blood cells (RBCs). In adults, EPO is mostly produced in the kidney’s peritubular
Publishing remains neutral with cells and released into the bloodstream. The EPO receptor (EPOR) on bone marrow
1
regard to jurisdictional claims in
published maps and institutional erythroid progenitors is bound to circulating EPO, initiating a number of signaling
2
affiliations pathways that promote the development of mature RBCs. It was originally isolated from
Volume 8 Issue 2 (2025) 55 doi: 10.36922/itps.5797