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INNOSC Theranostics and
Pharmacological Sciences Preclinical study of GBpoietin biosimilar

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analysis. Collectively, these results also demonstrate the GBpoietin and Eprex is essentially equivalent. Therefore,
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similarity between the two experimental EPO preparations, they can be considered biosimilar in pre-clinical settings,
namely GBpoietin and Eprex . with a clinical study in humans potentially providing
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Our result is in agreement with the findings of other further insights.
studies, where similar levels of biochemical parameters Acknowledgments
were reported (ALT/GPT, AST, and BUN). In our study,
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we reported that serum ATL/GPT increased in all the We thank Md. Harunur Rashid (the chairman of Globe
treatment groups. Serum AST and BUN also increased Pharmaceuticals Group of Companies) Ahmed Hossain,
beyond the normal level but the increases were less than Md. Mamunur Rashid, Md. Shahiduddin Alamgir and
that of the ALT/GPT levels in both single- and repeated- Abdullah Al Rashid (the directors of Globe Pharmaceuticals
dose toxicity tests. Similar studies suggest that the upper Group of Companies) for their continuous support and
level within the normal range of biochemical parameters encouragement. We thank Dr. Rustom Ali and Uttam
indicates the uniformity of liver function. It also serves as Barman for animal management, animal husbandry,
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evidence for non-toxicity of the test item under analysis. surgical process, and tissue preparation and scoring. We
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The observation suggests that GBpoietin is safe, with also thank Gini Biswas, Dibakor Paul, and Zahir Uddin
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a toxicity profile similar to that of the reference product Babor for their support of the information and facility
Eprex . management system.
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The results of the necropsies for both experiments
showed no indication of any abnormalities or anatomical Funding
changes. After two doses, the hemorrhagic regions were The study was funded by Globe Biotech Limited.
observed for single animal from each group (control,
placebo, and treatment groups). Presumably, the trauma Conflict of interest
from repeated subcutaneous injections at the same location Kakon Nag is the CEO of Globe Biotech Limited, Dhaka,
is associated with this symptom. Thus, the macroscopic Bangladesh and R&D Management Solution Inc., Ontario,
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results support the clinical findings, indicating no changes Canada. However, this has not influenced the content of
attributable to EPO and no signs of local irritation or injury. the manuscript. The other authors declare that they have
Regardless of the dosage or volume of administration, the no competing interests.
lack of macroscopic damage in the organs and tissues of
the experimental animals is a crucial factor in assessing Author contributions
the safety of the tested product in both trials. One of the
observed histopathological findings was the absence of Conceptualization: Kakon Nag, Naznin Sultana, Sitesh
lesions of pathological significance like degeneration Chandra Bachar
or cellular necrosis in internal organs. These reactions Formal analysis: Mohammad Mohiuddin, Md. Maksudur
have been described in the literature as a consequence Rahman Khan, Samir Kumar, Sheikh Rejaul Haq
of the intense metabolic activity of the organ, and their Investigation: Md. Enamul Haq Sarker, Bipul Kumar Biswas
spontaneous appearance has been reported for this animal Methodology: Mohammad Mohiuddin, Md. Maksudur
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species. The presence of these findings in the control Rahman Khan, Samir Kumar, Md. Enamul Haq
groups indicates that their occurrence is not dependent on Sarker, Bipul Kumar Biswas, Sitesh Chandra Bachar
the effect of the different rhEPO doses in any of the assayed Writing–original draft: Kakon Nag, Mohammad
formulations. Notably, the histopathological results Mohiuddin, Sheikh Rejaul Haq, Sitesh Chandra
further support the safety of the test product GBpoietin , Bachar, Naznin Sultana
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demonstrating similarity to the reference product Eprex . Writing–review & editing: Kakon Nag, Mohammad
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Mohiuddin, Sitesh Chandra Bachar, Naznin Sultana
5. Conclusion
This study establishes that the toxicological profiles of Ethics approval and consent to participate
GBpoietin and Eprex are similar and align with the The study plan and procedures for experiments were
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known pharmacology of EPO alfa. It is also important approved by the internal ethical review board (IECB-PCS:
to note that the histopathological results preclude any Internal Ethical Clearance Board for Pre-Clinical Study)
noticeable toxicity effect of the test product, GBpoietin , in of Globe Biotech Limited, which complies with local and
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major organs and injection sites. Based on the experimental international regulations. The ethical approval reference
results, we conclude that the biological response of number is GB/EC/19/001.

Volume 8 Issue 2 (2025) 65 doi: 10.36922/itps.5797