Skip to main content
Have a personal or library account? Click to login
Current regulatory and market environment for biosimilars in Serbia Cover

Current regulatory and market environment for biosimilars in Serbia

Slovenian Journal of Public Health
Volume 53 (2014): Issue 1 (March 2014)
By:  and    
Open Access
|Dec 2013
References

References

  1. 1. Giezen TJ, Mantel-Teeuwisse AK, Straus SM, Schellekens H, Leufkens HG, Egberts AC. Safety-related regulatory actions for biologicals approved in the United States and the European Union. J Am Med Assoc 2008; 300: 1887-96.
    Open DOISearch in Google Scholar
  2. 2. EvaluatePharma® World Preview to 2012, 6 June 2008.
    Search in Google Scholar
  3. 3. Kresse GB. Biosimilars - science, status and strategic perspective. Eur J Pharm Biopharm 2009; 72: 479-86.
    Open DOISearch in Google Scholar
  4. 4. Grabowski HG, Ridley DB, Schulman KA. Entry and competition in generic biologics. Managerial Decis Econ 2007; 28: 439-51.
    Open DOISearch in Google Scholar
  5. 5. Commission Regulation (EC) No. 726/2004 of 31 March 2004. Available February 7, 2013 at: http://eurlex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2004:136:0001:0033:e: PDF.
    Search in Google Scholar
  6. 6. Directive 2004/27/EC of the European Parliament and of the Council of 31 March 2004. Available May 17, 2013 at: http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2004:1 36:0034:0057:en:PDF.
    Search in Google Scholar
  7. 7. European Medicines Agency. Multidisciplinary: biosimilars. Available May 14, 2013 at: http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_ content_000408.jsp.
    Search in Google Scholar
  8. 8. European Medicines Agency. Guideline on similar biological medicinal product (CHMP/437/04). EMA, 2005.
    Search in Google Scholar
  9. 9. Zuniga L, Calvo B. Biosimilars approval process. Regul Toxicol Pharmacol 2010; 56: 374-7.
    Open DOISearch in Google Scholar
  10. 10. Zuniga L, Calvo B. Regulatory aspects of biosimilars in Europe. Trends Biotechnol 2009; 27: 385-7.
    Open DOISearch in Google Scholar
  11. 11. Braido F, Holgate S, Canonica GW. From “blockbusters” to “biosimilars”: an opportunity for patients, medical specialists and health care providers. Pulm Pharmacol Ther 2012; 25: 483-6.
    Open DOISearch in Google Scholar
  12. 12. Roger SD, Goldsmith D. Biosimilars: it’s not as simple as cost alone. J Clin Pharm Ther 2008; 33: 459-64.
    Open DOISearch in Google Scholar
  13. 13. Haussler B. Cost savings potential of biosimilars in the German health care system. In: Life science in the capital market biosimilars. DVFA, 2010.
    Search in Google Scholar
  14. 14. Datamonitor, biosimilars: strategic issues - potential remains unknown, Report No. DMHC2337. Datamonitor, London, 2007.
    Search in Google Scholar
  15. 15. IMS Health. Shaping the biosimilars opportunity: a global perspective on the evolving biosimilars landscape. IMS 2011: 4-5.
    Search in Google Scholar
  16. 16. Pejovic G, Filipovic J, Tasic Lj. How to remove barriers to medicines trade in emerging economies: the role of medicines regulatory authority in Serbia. Accred Qual Assur 2011; 16: 253-61.
    Open DOISearch in Google Scholar
  17. 17. Business Monitor International. Serbia pharmaceuticals and healthcare report Q1 2013. Available February 10, 2013 at: http:// www.marketresearch.com/Business-Monitor-International-v304/Serbia-Pharmaceuticals-Healthcare-Q1-7308777/.
    Search in Google Scholar
  18. 18. Adamski J, Godman B, Ofierska-Sujkowska G, Wendykowska K, Laius O, Jan S et al. Risk sharing arrangements for pharmaceuticals: potential considerations and recommendations for European payers. BMC Health Serv Res 2010; 10: 153-68.
    Open DOISearch in Google Scholar
  19. 19. Medicines and Medical Devices Agency of Serbia. Medicine consumption and market data for 2007. Available February 16, 2013 at: http://www.alims.gov.rs/ciril/files/2012/09/03-Prometi-potrosnja-lekova-2007.pdf.
    Search in Google Scholar
  20. 20. Medicines and Medical Devices Agency of Serbia. Medicine consumption and market data for 2008. Available February 16, 2013 at: http://www.alims.gov.rs/ciril/files/2012/09/04-Prometi-potrosnja-lekova-2008.pdf.
    Search in Google Scholar
  21. 21. Medicines and Medical Devices Agency of Serbia. Medicine consumption and market data for 2009. Available February 16, 2013 at: http://www.alims.gov.rs/ciril/files/2012/09/05-Prometi-potrosnja-lekova-2009.pdf.
    Search in Google Scholar
  22. 22. Medicines and Medical Devices Agency of Serbia. Medicine consumption and market data for 2010. Available February 16, 2013 at: http://www.alims.gov.rs/ciril/files/2013/02/Promet_2010.pdf.
    Search in Google Scholar
  23. 23. Medicines and Medical Devices Agency of Serbia. Medicine consumption and market data for 2011. Belgrade: Medicines and Medical Devices Agency of Serbia, 2012.
    Search in Google Scholar
  24. 24. National Health Insurance Institution. Positive medicine lists. Available February 5, 2013 at: http://www.rfzo.rs/index.php/ ekovi-actual/02012013.
    Search in Google Scholar
  25. 25. Generics and Biosimilars Iniciative. European uptake of biosimilars. Available May 16, 2013 at: http://www.gabionline.net/Reports/European-uptake-of-biosimilars/(highlight)/ biosimilar%20uptake.
    Search in Google Scholar
  26. 26. Declerck PJ, Simoens S. A European perspective on the market accessibility of biosimilars. Biosimilars 2012; 2: 33-40.
    Search in Google Scholar
  27. 27. European Commission. What you need to know about biosimilar medicinal product, a consensus information document. Available May 20, 2013 at: http://ec.europa.eu/enterprise/sectors/healthcare/files/docs/biosimilars_report_en.pdf.
    Search in Google Scholar
DOI: https://doi.org/10.2478/sjph-2014-0011 | Journal eISSN: 1854-2476 | Journal ISSN: 0351-0026
Journal RSS Feed
Language: English, Slovenian
Page range: 101 - 114
Published on: Dec 13, 2013
Published by: National Institute of Public Health, Slovenia
In partnership with: Paradigm Publishing Services
Keywords:
biosimilar,
medicine regulatory authority,
consumption,
Serbia,
marketing authorisation
Related subjects:
Medicine,
Clinical medicine,
Hygiene and environmental medicine

© 2013 Gordana Pejović, Jovan Filipović, published by National Institute of Public Health, Slovenia
This work is licensed under the Creative Commons License.

Volume 53 (2014): Issue 1 (March 2014)
Previous article
Next article