THE WORLD PRACTICE IN THE ASSESSMENT OF THE INTERCHANGEABILITY OF BIOENGINEERED DRUGS


如何引用文章

全文:

开放存取 开放存取
受限制的访问 ##reader.subscriptionAccessGranted##
受限制的访问 订阅或者付费存取

详细

In this article, main terms and definitions related to biosimilars, generic and original drugs are given. Furthermore, history brief of biotechnical industry rise and development with drugs produced by bio objects is presented. Here, main differences between biosimilars and generic drugs are explained, as well as their difference from brand-name drug. Biotechnical process and main application area of biosimilars are reviewed. Rules and regulations in Russia and EU are analyzed.

全文:

受限制的访问

作者简介

V. Smirnov

cientific Centre for Expert Evaluation of Medicinal Products of the Ministry of Health of the Russian Federation, I.M. Sechenov First Moscow State Medical University

Email: Bunyatyan@expmed.ru

L. Krasnykh

Scientific Centre for Expert Evaluation of Medicinal Products of the Ministry of Health of the Russian Federation

Email: Bunyatyan@expmed.ru

V. Merkulov

Scientific Centre for Expert Evaluation of Medicinal Products of the Ministry of Health of the Russian Federation

Email: Bunyatyan@expmed.ru

N. Bunyatyan

cientific Centre for Expert Evaluation of Medicinal Products of the Ministry of Health of the Russian Federation, I.M. Sechenov First Moscow State Medical University

Email: Bunyatyan@expmed.ru

G. Ramenskaya

cientific Centre for Expert Evaluation of Medicinal Products of the Ministry of Health of the Russian Federation, I.M. Sechenov First Moscow State Medical University

Email: Bunyatyan@expmed.ru

E. Yeltsova

Scientific Centre for Expert Evaluation of Medicinal Products of the Ministry of Health of the Russian Federation

Email: Bunyatyan@expmed.ru

E. Smolyarchuk

M. Sechenov First Moscow State Medical University

Email: Bunyatyan@expmed.ru

E. Yegorenkov

M. Sechenov First Moscow State Medical University

Email: Bunyatyan@expmed.ru

A. Bushmanova

M. Sechenov First Moscow State Medical University

Email: Bunyatyan@expmed.ru

参考

  1. На мировом фармрынке доминируют биопрепараты URL:http://www. pharmvestnik.ru/publs/lenta/obzory/na-mirovom-farmrynke-dominirujut- biopreparaty.html#.U0wwBFV_tc0
  2. Об обращении лекарственных средств [Электронный ресурс]: Федеральный закон от 12.04.2010 №61-ФЗ (ред. от 12.03.2014). Доступ из справ.-правовой системы «КонсультантПлюс»
  3. Федеральный закон от 22.12.2014 №429 «О внесении изменения в Федеральный закон «Об обращении лекарственных средств» / Министерство здравоохранения Российской Федерации [официальный сайт]. URL: http:// rosminzdrav.ru/docs/mzsr/projects/1926
  4. Biosimilars: anoverview. URL:file:///C:/Documents%20and%20Settings/ Admin/%D0%9C%D0%BE%D0%B8%20%D0%B4%D0%BE%D0%BA%D1%83%D 0%BC%D0%B5%D0%BD%D1%82%D1%8B/Downloads/3deec51aecf8dc7a73.pdf
  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. Guidelineon 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%20 Guideline%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 (дата обращения 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: 113-8
  18. Misra A. Are biosimilars really generics? // Expert Opin. Biol. Ther. - 2010; 10 (4): 489-94
  19. Sahoo N., Choudhury K., Manchikanti P. Manufacturing of biodrugs: need for harmonization in regulatory standards // Biodrugs. - 2009; 23: 217-29
  20. 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
  21. 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

补充文件

附件文件
动作
1. JATS XML
下载

版权所有 © Russkiy Vrach Publishing House, 2015
##common.cookie##