COMPARATIVE STUDY OF INTERACTION OF SOME DOMESTIC HUMAN INSULIN SUBSTANCES AND ITS ANALOGUES WITH INSULIN RECEPTOR BY METHOD OF SURFACE PLASMON RESONANCE
Abstract
The high demand for insulin preparations by the population of the country makes it urgent to create domestic bioanalogues for the treatment of diabetes mellitus. The equivalency of the quality, safety and efficacy of the bioanalogue with the reference medicinal preparation registered in Russia is required by authority at the stage of preclinical studies. The aim of the study was to study the interaction of insulin substances of domestic production, including short and long-acting insulin with the insulin receptor in comparison with the reference substances registered in Russia by the surface plasmon resonance method. Comparing the interaction kinetics curves and calculated dissociation constants determined by the surface plasmon resonance method it was confirmed that there are no statistically significant differences between the potentially bioanalogical insulin substances Rosinsulin R, Rosinsulin Glargin and Rosinsulin Aspart (LLC ”Zavod Medsintez”, Russia) and the corresponding substances of registered in Russia medicines.
About the Authors
I. N. Urakova
St.-Petersburg Institute of Pharmacy
Russian Federation
Russian Federation
K. L. Kryshen
RMC «HOUSE OF PHARMACY» JSC
Russian Federation
Russian Federation
O. N. Pozharitskaya
St.-Petersburg Institute of Pharmacy
Russian Federation
Russian Federation
M. V. Gavrilin
LLC «Zavod Medsintez»
Russian Federation
Russian Federation
A. N. Shikov
St.-Petersburg Institute of Pharmacy
Russian Federation
Russian Federation
M. N. Makarova
RMC «HOUSE OF PHARMACY» JSC
Russian Federation
Russian Federation
V. G. Makarov
RMC «HOUSE OF PHARMACY» JSC
Russian Federation
Russian Federation
References
1. Khabriev R. U., Kamaev N. O., Danilova T. I., Kakhoyan E. G. Biopharmaceuticals and the features of monitoring their quality // Bulletin of Roszdravnadzor. 2015. № 6. C. 55-59.
2. Protsenko M. V., Yagudina R. I. Biotechnological medicinal products and biolike preparations: a review of practical application and regulatory framework of treatment regulation // Pharmacoeconomics. 2010. T. 3. № 4. S. 13-21.
3. Orlov S. V., Shimanovskii N. L., Fogt S. N. Is it possible to use the bioavailant bevacizumab for all indications recorded for the original drug? // Research and practice in medicine.2016. T. 3. № 2. S. 45-52.
4. Margaeva B. Yu. Approaches to the assessment of the interchangeability of bioanalys (biosimilars) at the stage of their state registration in the light of the implementation of the "Pharma-2020" strategy // Development and registration of medicines. 2013. № 3(4). S. 88-94.
5. Федеральный закон от 12.04.2010 № 61-ФЗ (ред. от 28.12.2017) «Об обращении лекарственных средств».
6. Soldatov A. A., Avdeeva Zh. I., Alpatova N. A., Medunitsyn N. V., Mosyagin V. D., Gaiderova L. A., Yakovlev A. K., Bondarev V. P., Mironov A. N. Proof of the similarity of recombinant epoetins registered on the basis of the principles of "biosimilars" (physico-chemical and biological properties) // Biopreparations. 2014. T. 1. № 49. S. 11-22.
7. Proskurina I. A., Maiorov A. Yu., Goryachev D. V., Bunyatyan N. D. Modern approaches to the evaluation of the pharmacokinetics and pharmacodynamics of biosimilar genetically engineered preparations of human insulin and human insulin analogues within the framework of the Phase I clinical trial. // Diabetes mellitus. 2016. T. 19. № 3. S. 251-259.
8. Guideline on non-clinical and clinical development of similar biological medicinal products containing recombinant human insulin and insulin analogues (EMEA/CHMP/BMWP/32775/2005_ Rev. 1). URL: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2015/03/WC500184161.pdf (дата обращения 02.08.2018).
9. Руководство по экспертизе лекарственных средств. Т. IV. - М.: Полиграф-Плюс. 2014. С. 54.
10. Schasfoort R. B. M., Tudos A. J. Handbook of Surface Plasmon Resonance. - Cambridge: The Royal Society of Chemistry. 2008. 403 p.
11. Ivanov A. S., Medvedev A. E. Optical plasmon resonance biosensor in molecular phishing // Biomedical chemistry. 2015. V. 61. C. 231-238.
12. Mariani S., Minunni M. Surface plasmon resonance applications in clinical analysis // Analytical and Bioanalytical Chemistry. 2014. V. 406. C. 2303-2323.
13. Shalabney A., Abdulhalim I. Sensitivity-enhancement methods for surface plasmon sensors // Lasers and Photonics Reviews. 2011. V. 5. C. 571-606.
14. Situ C., Buijs J., Mooney M. H., Elliott C. T. Advances in surface plasmon resonance biosensor technology towards highthroughput, food-safety analysis // Trends in Analytical Chemistry. 2010. V. 29. C. 1305-1315.
15. Soll R., Beck-Sickinger A. On the role of neuropeptides in the hypothalamic regulation of food intake // Current Medicinal Chemistry-Immunology, Endocrine & Metabolic Agents. 2001. V. 1(2). P. 151-169.
16. Czech M. P. The nature and regulation of the insulin receptor: structure and function // Annu Rev Physiol. 1985. V. 47. P. 357-81.
17. Shanik M., Xu Y., Škrha J., Dankner R., Zick Y., Roth J. Insulin resistance and hyperinsulinemia // Diabetes Care. 2008. V. 31. Suppl. 2. P. 262.
18. Nakagawa S. H., Tager H. S., Steiner D. F. Mutational Analysis of Invariant Valine B12 in Insulin: Implications for Receptor Binding // Biochemistry. 2000. V. 39 (51). P. 15826-15835.
19. Menting J. G., Whittaker J., Margetts M. B., Whittaker L. J., Kong GK-W., Smith B. J., Watson C. J., Žáková L., Kletvíková E., Jiráček J. How insulin engages its primary binding site on the insulin receptor // Nature. 2013. V. 493 (7431). P. 241-245.
20. Schäffer L. A model for insulin binding to the insulin receptor // Eur. J. Biochem. 1994. V. 221(3). P. 1127-1132.
21. De Meyts P., Whittaker J. Structural biology of insulin and IGF1 receptors: implications for drug design // Nature Reviews Drug Discovery. 2002. V. 1(10). P. 769-783.
22. Lawrence M. C., McKern N. M., Ward C. W. Insulin receptor structure and its implications for the IGF-1 receptor // Current Opinion in Structural Biology. 2007. V. 17(6). P. 699-705.
23. Ward C. W., Lawrence M. C., Streltsov V. A., Adams T. E., McKern N. M. The insulinand EGF receptor structures: new insights into ligandinduced receptor activation // Trends in Biochemical Sciences. 2007. V. 32(3). P. 129-137.
Review
For citations:
Urakova I.N., Kryshen K.L., Pozharitskaya O.N., Gavrilin M.V., Shikov A.N., Makarova M.N., Makarov V.G. COMPARATIVE STUDY OF INTERACTION OF SOME DOMESTIC HUMAN INSULIN SUBSTANCES AND ITS ANALOGUES WITH INSULIN RECEPTOR BY METHOD OF SURFACE PLASMON RESONANCE. Drug development & registration. 2018;(3):136-143. (In Russ.)
Views:
698
Email this article 