PROSPECTIVE METHODS OF ASSESSING DRUGS INTERCHANGEABILITY


Cite item

Full Text

Open Access Open Access
Restricted Access Access granted
Restricted Access Subscription or Fee Access

Abstract

To optimize prospective methods of evaluation of drugs interchangeability a patent research was conducted. The results of the patent research are presented in this article. The outcome of this exploration will help to optimize the process of comparative evaluation of the reference drug and generic (or biosimilar).

Full Text

Restricted Access

About the authors

A. Pereverzev

Scientific Centre for Expert Evaluation of Medicinal Products of the Ministry of Health of Russia

Email: Pereverzev@expmed.ru

B. Romanov

Scientific Centre for Expert Evaluation of Medicinal Products of the Ministry of Health of Russia

R. Alyautdln

Scientific Centre for Expert Evaluation of Medicinal Products of the Ministry of Health of Russia

N. Bunyatyan

Scientific Centre for Expert Evaluation of Medicinal Products of the Ministry of Health of Russia

A. Elapov

Scientific Centre for Expert Evaluation of Medicinal Products of the Ministry of Health of Russia

References

  1. Godman B., Wettermark B., Bishop I. et al. European payer initiatives to reduce prescribing costs through use of generics // GaBI J. - 2012; 1: 22-7
  2. Ministry of Health. Labour and Welfare of Japan. Policy Report: Promotion of the use of generic drugs; 2012. Available at: http://www.mhlw.go.jp/english/policy_report/2012/09/120921.html
  3. Andersson K., Bergstrom G., Petzold M. et al. Impact of a generic substitution reform on patients’ and society’s expenditure for pharmaceuticals // Health Policy. - 2007; 81: 376-84.
  4. Coombes R. GPs save £400m in 2008 by increasing use of generic drugs // BMJ. - 2009; 338: b2044
  5. European Generic Medicines Association (EGA). Ega fact sheet on generic medicines: generic medicines provide front-Line treatment for chronic illnesses & conditions. Available at: http://198.170.119.137/doc/ega_factsheet-02.pdf.
  6. European Generic Medicines Association (EGA). Frequently fsked questions about generic medicines; 2007. Available at: http://198.170.119.137/doc/FAQ_generics.pdf.
  7. Godman B., Shrank W., Wettermark B. et al. Use of genericsda critical cost containment measure for all healthcare professionals in Europe? // Pharmaceuticals. - 2010; 3: 2470-94.
  8. Sheppard A. Generic medicines: essential contributors to the long-term health of society. IMS Health. Available at: http://www.imshealth.com/imshealth/Global/Content/Document/Market_Measurement_TL/Generic_Medicines_GA.pdf.
  9. Аляутдин Р.Н., Романов Б.К., Переверзев А.П. и др. Электронная система выписывания рецептов и безопасность лекарственной терапии // Ведомости научного центра экспертизы средств медицинского применения. - 2014; 2: 30-4.
  10. Duerden M., Hughes D. Generic and therapeutic substitutions in the UK: are they a good thing? // Br. J. Clin. Pharmacol. - 2010; 70: 335-41.
  11. Ferner R., Lenney W., Marriott J. Controversy over generic substitution // BMJ. - 2010; 340: 3570.
  12. Holmes D., Becker J., Limacher M. et al. ACCF/AHA 2011 health policy statement on therapeutic interchange and substitution: a report of the American College of Cardiology Foundation Clinical Quality Committee // Circulation. - 2011; 124: 1290-310.
  13. Сводный отчет о проведении оценки регулирующего воздействия (Цит. по http://regulation.gov.ru/project/22466.html, дата обращения -12.01.2015).
  14. Федеральный Закон № 429-ФЗ от 22.12.2014 «О внесении изменений в федеральный закон «Об обращении лекарственных средств»» (Цит. по сист. «Консультант плюс», дата обращения - 12.01.2015).
  15. Федеральный закон от 12.04.2010 № 61-ФЗ (ред. от 22.10.2014) «Об обращении лекарственных средств» (Цит. по сист. «Консультант Плюс», дата обращения - 12.01.2015).
  16. Multisource (generic) pharmaceutical products: guidelines on registration requirements to establish interchangeability. WHO Technical Report Series, No. 937, 2006 (Цит. по http://www.who.int/medicines/areas/quality_safety/quality_ assurance/MultisourcePharmaProductsGuidelinesRegistrationRequirementsInterchangeabilityTRS937Annex7.pdf, дата обращения - 12.01.2015).
  17. Mei-Ling Chen. Harmonization of regulatory approaches for evaluating therapeutic equivalence and interchangeability of multisource drug products: workshop summary report // AAPS J. - 2011; 13 (4): 556-64.

Supplementary files

Supplementary Files
Action
1. JATS XML

Copyright (c) 2015 Russkiy Vrach Publishing House

This website uses cookies

You consent to our cookies if you continue to use our website.

About Cookies