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Current regulatory and market environment for biosimilars in Serbia


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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: 1887-96.10.1001/jama.300.16.188718940975Search in Google Scholar

2. EvaluatePharma® World Preview to 2012, 6 June 2008.Search in Google Scholar

3. Kresse GB. Biosimilars - science, status and strategic perspective. Eur J Pharm Biopharm 2009; 72: 479-86.10.1016/j.ejpb.2009.02.01419286455Search in Google Scholar

4. Grabowski HG, Ridley DB, Schulman KA. Entry and competition in generic biologics. Managerial Decis Econ 2007; 28: 439-51.10.1002/mde.1352Search in Google Scholar

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. 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. 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. European Medicines Agency. Guideline on similar biological medicinal product (CHMP/437/04). EMA, 2005.Search in Google Scholar

9. Zuniga L, Calvo B. Biosimilars approval process. Regul Toxicol Pharmacol 2010; 56: 374-7.10.1016/j.yrtph.2009.11.00419925842Search in Google Scholar

10. Zuniga L, Calvo B. Regulatory aspects of biosimilars in Europe. Trends Biotechnol 2009; 27: 385-7.10.1016/j.tibtech.2009.03.00519467723Search in Google Scholar

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: 483-6.10.1016/j.pupt.2012.09.00523010202Search in Google Scholar

12. Roger SD, Goldsmith D. Biosimilars: it’s not as simple as cost alone. J Clin Pharm Ther 2008; 33: 459-64.10.1111/j.1365-2710.2008.00942.x18834359Search in Google Scholar

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. Datamonitor, biosimilars: strategic issues - potential remains unknown, Report No. DMHC2337. Datamonitor, London, 2007.Search in Google Scholar

15. IMS Health. Shaping the biosimilars opportunity: a global perspective on the evolving biosimilars landscape. IMS 2011: 4-5.Search in Google Scholar

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: 253-61.10.1007/s00769-010-0749-7Search in Google Scholar

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. 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: 153-68.10.1186/1472-6963-10-153290645720529296Search in Google Scholar

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. 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. 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. 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. 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. 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. 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. Declerck PJ, Simoens S. A European perspective on the market accessibility of biosimilars. Biosimilars 2012; 2: 33-40.Search in Google Scholar

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

eISSN:
1854-2476
ISSN:
0351-0026
Język:
Angielski
Częstotliwość wydawania:
4 razy w roku
Dziedziny czasopisma:
Medicine, Clinical Medicine, Hygiene and Environmental Medicine