Abstract
The article presents the results of the study of the effectiveness and safety of Insulin glargine «Farmak» in comparison with the drug Lantus SoloStar in patients with type 1 diabetes. As medicines lose the patent protection term, it enables the development and launch of biosimilar products in the pharmaceutical market, which are reproduced versions of the original drug. Given the complexity of the structure of biological products, the impossibility of accurate reproduction of technological production, since both the molecule and technology are patented by the brand, biosimilars are not a copy of the original drugs, but only similar drugs. Considering the above mentioned, an overview of clinical studies and own results of the study of the Aylar biosimilar compared to the original glargine molecule was conducted. On the basis of the analysis, it can be claimed that the study drug has good tolerance, does not affect fatalities, does not lead to an increase in the antibody titer to insulin, does not impair laboratory performance. Insulin glargine 100 U/ml per 3 ml in a cartridge produced by PJSC «Farmak» are equivalent to Lantus SoloStar 100 U/ml per 3 ml in a cartridge produced by Sanofi-Aventis in patients with type 1 diabetes. During the period of application of the drug, no statistically and clinically significant differences in the dynamics of HbA1c, onset glycemia, profile parameters, and dynamics of total doses of insulin in both groups were found.
References
2. The Commission of the European Communities (2003) Commission Directive 2003/63/EC of 25 June 2003 amending Directive 2001/83/EC of
the European Parliament and of the Council on the Community code relating to medicinal products for human use // In Official Journal of
the European Union. — 2003. — LI59. — P. 46-94.
3. Наказ МОЗ № 460 від 23.07.2015.
4. Report medicines in development — Biotechnology // PhRMA. — 2006.
5. The European Parliament and the Council of the European Union (2001) Directive 2001/83/EC of the European Parliament and of the Council
of 6 November 2001 on the Community code relating to medicinal products for human use //In Official Journal of the European Union. — 2001. — L311. — P. 67-128.
6. Home P. Biosimilar insulins // Diabetes Voice. — 2011. — № 56 (2). — P. 41-43.
7. Schellekens H. Biosimilar therapeutics — what do we need to consider? // NDT Plus. — 2009. — № 2 (Suppl 1). — i27-i36. doi: 10.1093/ndtplus/sfnl77.
8. Kuhlmann M., Marre M. Lessons learned from biosimilar epoetins and insulins // Br J. Diabetes Vase Dis. — 2010. — № 10. — P. 90-97.
9. Roger S.D. and Ashraf M. Biosimilars: Opportunity or Cause for Concern? // J. Pharm. Pharmaceut. Sei. — 2007. — № 10 (3). — P. 405-410.
10. The European Parliament and the Council of the European Union (2004) Directive 2004/27/EC of the European Parliament and of the Council
of 31 March 2004 amending Directive 2001 /83/EC on the Community code relating to medicinal products for human use // In Official Journal of the European Union. — 2001. — LI 36. — Р. 34-57.
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