Page 72 - ITPS-8-2

INNOSC Theranostics and
Pharmacological Sciences Preclinical study of GBpoietin biosimilar

Consent for publication doi: 10.1002/jps.24164

Not applicable. 10. Dzierzak E, Philipsen S. Erythropoiesis: Development
and differentiation. Cold Spring Harb Perspect Med.
Availability of data and materials 2013;3(4):a011601.

The data that support the findings of this study are available doi: 10.1101/cshperspect.a011601
within the article or are available from the corresponding 11. Committee for Medicinal Products for Human Use
author upon reasonable request. (CHMP). Guideline on Comparability of Medicinal Products
Containing Biotechnology-Derived Proteins as Active
Further disclosure Substance. Non-Clinical and Clinical Issues. Netherlands:
European Medicines Agency; 2003.
The study was published in the preprint journal BioRxiv
under the title “Preclinical study of the human recombinant 12. Guideline IHT. Guidance on Nonclinical Safety Studies
Erythropoietin (GBPD002) compared with Eprex ” with a for the Conduct of Human Clinical Trials and Marketing
®
Authorization for Pharmaceuticals M3 (R2); 2009.
DOI number 10.1101/2024.06.05.597513.
13. Parnham MJ, Schindler‐Horvat J, Kozlović M. Non‐
References clinical safety studies on biosimilar recombinant
human erythropoietin. Basic Clin Pharmacol Toxicol.
1. Al Mahtab M, Bachar SC, Nag K, et al. Clinical evaluation
in adult human revealed the biosimilarity of recombinant 2007;100(2):73-83.
Erythropoietin GBPD002 with eprex . Arch Clin Biomed doi: 10.1111/j.1742-7843.2007.00028.x
®
Res. 2023;7(4):459-474.
14. Thachil J, Owusu-Ofori S, Bates I. Haematological diseases
doi: 10.26502/acbr.50170361 in the tropics. In: Manson’s Tropical Infectious Diseases.
Amsterdam: Elsevier Health Sciences; 2014. p. 894.
2. Bhoopalan SV, Huang LJ, Weiss MJ. Erythropoietin
regulation of red blood cell production: From bench to 15. Weber G, Gross J, Kromminga A, Loew HH, Eckardt KU.
bedside and back. F1000Res. 2020;9:F1000 Faculty Rev-1153. Allergic skin and systemic reactions in a patient with pure red
cell aplasia and anti-erythropoietin antibodies challenged
doi: 10.12688/f1000research.26648.1
with different epoetins. J Am Soc Nephrol. 2002;13(9):
3. Miyake T, Kung CK, Goldwasser E. Purification of human 2381-2383.
erythropoietin. J Biol Chem. 1977;252(15):5558-5564.
doi: 10.1097/01.asn.0000027031.79843.6c
4. Igarashi P. Kidney-specific gene targeting. J Am Soc Nephrol. 16. Lewis LD. Preclinical and Clinical Studies: A Preview of
2004;15(8):2237-2239.
Potential Future Applications of Erythropoietic Agents.
doi: 10.1097/01.ASN.0000136298.09488.D7 Netherlands: Elsevier; 2004. p. 17-25.
5. Jelkmann W. Physiology and pharmacology of erythropoietin. 17. Singh G. Preclinical Drug Development. In: Pharmaceutical
Transfus Med Hemother. 2013;40(5):302-309. Medicine and Translational Clinical Research. Netherlands:
Elsevier; 2018. p. 47-63.
doi: 10.1159/000356193
18. Broichhausen C, Riquelme P, Ahrens N, et al. In question:
6. Bacardí DM, Cosme K, Gutiérrez A, et al. Preclinical safety
demonstration of the human recombinant erythropoietin The scientific value of preclinical safety pharmacology
HEBERITRO . Biotecnol Apl. 2005;22(4):273-278. and toxicology studies with cell-based therapies. Mol Ther
®
Methods Clin Dev. 2014;1:14026.
7. Shih HM, Wu CJ, Lin SL. Physiology and pathophysiology
of renal erythropoietin-producing cells. J Formos Med Assoc. doi: 10.1038/mtm.2014.26
2018;117(11):955-963. 19. De Mora F, Torres R. Biotechnology-derived medicines:
What are they? A pharmacological and a historical
doi: 10.1016/j.jfma.2018.03.017
perspective. J Generic Med. 2010;7(2):145-157.
8. Zhang Y, Wang L, Dey S, et al. Erythropoietin action in
stress response, tissue maintenance and metabolism. Int J doi: 10.1057/jgm.2010.10
Mol Sci. 2014;15(6):10296-10333. 20. Beiraghdar F, Panahi Y, Einollahi B, et al. Evaluation of a
biosimilar recombinant alpha epoetin in the management
doi: 10.3390/ijms150610296
of anemia in hemodialysis patients. Saudi Pharm J.
9. Pucaj K, Riddle K, Taylor SR, Ledon N, Bolger GT. 2015;23(5):544-548.
®
Safety and Biosimilarity of ior EPOCIM compared with
eprex based on toxicologic, pharmacodynamic, and doi: 10.1016/j.jsps.2015.02.007
®
pharmacokinetic studies in the sprague-dawley Rat. J Pharm 21. Nag K, Islam MJ, Rahman Khan MM, et al. Development
Sci. 2014;103(11):3432-3441. and qualification of a high-yield recombinant human

Volume 8 Issue 2 (2025) 66 doi: 10.36922/itps.5797