Biosimilars - drugs of the future
Abstract
The article describes the basic terms and definitions relating to biosimilars, generics and original drugs. Also described a brief history of the origin and development of the biotechnology industry and drugs produced using biological objects. The main difference between biosimilars and generics, as well as their differences to innovative medicines. The process of biotechnological production, and main applications of biosimilars. It analyzed the legal framework of the Russian Federation and the European Union.
About the Authors
E. A. Eltcova
First Moscow State Medical University named after I.M. Sechenov
Russian Federation
Russian Federation
G. V. Ramenskaya
First Moscow State Medical University named after I.M. Sechenov
Russian Federation
Russian Federation
E. A. Smolyarchuk
First Moscow State Medical University named after I.M. Sechenov
Russian Federation
Russian Federation
A. V. Bushmanova
First Moscow State Medical University named after I.M. Sechenov
Russian Federation
Russian Federation
References
1. На мировом фармрынке доминируют биопрепараты URL:http://www.pharmvestnik.ru/publs/lenta/obzory/na-mirovom-farmrynke-domimrujut-biopreparaty.html#.U0wwBFV_tc0.
2. Об обращении лекарственных средств [Электронный ресурс]: Федеральный закон от 12.04.2010 N 61-ФЗ (ред. от 12.03.2014). Доступ из справ.-правовой системы «Консультант Плюс».
3. Проект Федерального закона от 21.01.2013 г. «О внесении изменений в Федеральный закон «Об обращении лекарственных средств» и в статью 333.32.1. части второй Налогового кодекса Российской Федерации».
4. Biosimilars: a overview. http://www.researchgate.net/publication/228730641_Biosimilars_an_overview.
5. Annex to Guideline on Similar Biological Medicinal Products Containing Biotechnology derived Proteins as Drug Substance -Non Clinical and Clinical Issues containing Recombinant Granulocyte Colony-Stimulating Factor, CHMP/31329/05, February 2006. URL: www.ema.europa. eu/pdfs/human/biosimilar/3132905en
6. Annex to Guideline on Similar Biological Medicinal Products Containing Biotechnology derived Proteins as Drug Substance - Non Clinical and Clinical Issues containing Recombinant Human Erythropoietin, CHMP/94526/05, March 2006. URL: www.ema.europa.eu/pdfs/human/ biosimilar/9452605en. Accessed 02 September 2010.
7. Annex to Guideline on Similar Biological Medicinal Products Containing Biotechnology derived Proteins as Drug Substance- Non Clinical and Clinical Issues containing Recombinant Human Growth Hormone, CHMP/94528/05, February 2006. URL: www.ema.europa.eu/pdfs/human/ biosimilar/9452805en.
8. Guideline on Immunogenicity Assessment of Biotechnology-derived Therapeutic Proteins. EMEA/CHMP/BMWP/14327/2006, December 2007. URL:http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003946.pdf.
9. 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., December 2012. URL:http://www.ema.europa.eu/docs/en_GB/document_library/ Scientific_guideline/2012/12/WC500136392.pdf.
10. Guideline on Similar Biological MedicinalProducts, CPMP/437/04, October 2005. URL:http://www.ema.europa.eu/docs/en_GB/document_ library/Scientific_guideline/2009/09/WC500003517.pdf (дата обращения 14.04.2014).
11. Guideline on Similar Biological Medicinal Products Containing Biotechnology-derived Proteins as Drug Substance - Non Clinical and Clinical Issues, EMEA/CHMP/BMWP/42832/05, February 2006. URL: http://www.triskel.com/2%20Guideline%20biotech%20derived%20proteins. pdf.
12. Guideline on Similar Biological MedicinalProducts containing biotechnology-derived proteins as active substance: quality issues (revision 1). EMA, Committee for Medicinal Products for Human Use, 2012. URL:http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_ guideline/2012/05/WC500127960.pdf (датаобращения 14.04.2014).
13. Guideline on Similar Biological Medicinal Products Containing Low-molecular Weight Heparins. Draft released for consultation in April 2008. URL: www.ema.europa.eu/pdfs/human/biosimilar/11826407en.
14. Guideline on similar biological medicinal products containing monoclonal antibodies - non-clinical and clinical issues, CHMP/ BMWP/403543/2010, May 2012. URL:http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2012/06/ WC500128686.pdf.
15. Guideline on similar biological medicinal products containing recombinant interferon alpha, CHMP/BMWP/102046/2006, October 2007. URL:http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003931.pdf.
16. IMS Health 2007 & 2009, Evaluate Pharma, Sandoz analysis.
17. Jenkins N., Murphy L., Tyther R. Post-translational modifications of recombinant proteins: significance for biopharmaceuticals. // Mol. Biotechnol.- 2008. - № 39. - Р. 113-118.
18. Misra A. Are biosimilars really generics? // Expert Opin. Biol. Ther. - 2010. - № 10(4). - Р. 489-494.
19. Goldsmith D., Kuhlmann M., Covic A. Through the looking glass: the protein science of biosimilars. // ClinExpNephrol. 2007;11: 191 - 195.
20. Sahoo N., Choudhury K., Manchikanti P. Manufacturing of biodrugs: need for harmonization in regulatory standards. // Biodrugs. 2009;23: 217-229.
21. 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. - L159. - Р. 46-94.
22. 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, L136, pp. 34-57.
Review
For citations:
Eltcova E.A., Ramenskaya G.V., Smolyarchuk E.A., Bushmanova A.V. Biosimilars - drugs of the future. Pharmacokinetics and Pharmacodynamics. 2015;(1):12-15. (In Russ.)
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