Biosimilars - Specific features of the approval process in the European Union;Biosimilars - Specifika schvalovacího procesu v EU

Klinicka Farmakologie a Farmacie

Volumn 28, Issue 1, 2014, Pages 14-18

  Strojil, Jan ^a  

^a PALACKÝ UNIVERSITY   (Czech Republic)

Author keywords

Biologics; Biosimilars; Drug approval; Infliximab; Regulation

Indexed keywords

BIOSIMILAR AGENT; INFLIXIMAB;

ARTICLE; DRUG APPROVAL; DRUG NOMENCLATURE; EUROPEAN UNION; GOVERNMENT REGULATION; HUMAN; PATENT; PATIENT INFORMATION; PHYSICIAN; PROCESS MODEL;

EID: 84897538705     PISSN: 12127973     EISSN: 18035353     Source Type: Journal    
DOI: None     Document Type: Article

References (15)

1. Megerlin F, Lopert R, Taymor K, Trouvin J-H. Biosimilars And The European Experience: Implications For The United States. Health Aff. 2013; 32(10): 1803-1810.
2. Woodcock J, Griffin J, Behrman R, Cherney B, Crescenzi T, Fraser B, et al. The FDA's assessment of follow-on protein products: a historical perspective. Nat Rev Drug Discov. 2007; 6(6): 437-442.
3. WHO {divides}WHO Drug Information [Internet]. WHO. [cited 2014 Jan 2]. Available from: http://www.who.int/medicines/publications/druginformation/issues/DrugInfo09vol23_2/en/index.html.
4. EMA. Guideline on Similar Biological Medicinal Products [Internet]. 2013 [cited 2014 Jan 2]. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2013/05/WC500142978.pdf.
5. EMA. Guideline on similar biological medicinal products containing monoclonal antibodies - non-clinical and clinical issues [Internet]. 2012 [cited 2014 Jan 2]. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2012/06/WC500128686.pdf.
6. Lepage-Nefkens I, Gerkens S, Piérart J, Hulstaert F, Farfan Portet MI. Barriers and opportunities for the uptake of biosimilar medicines in Belgium [Internet]. Available from: https://kce.fgov.be/sites/default/files/page_documents/KCE_199_2012-13-HSR_Biosimilars_report_0.pdf.
7. EMA. Assessment report - Inflectra [Internet]. 2013. Available from: http://www.ema.europa.eu/docs/en_GB/do-cument_library/EPAR_-_Public_assessment_report/hu-man/002778/WC500151490.pdf.
8. EMA. Refusal Assessment report - Alpheon [Internet]. 2006. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Public_assessment_report/human/002778/WC500151490.pdf.
9. GEN {divides}Insight & Intelligence™: Following Up on Follow-On Biologics [Internet]. GEN. [cited 2014 Jan 2]. Available from: http://www.genengnews.com/insight-and-intelli-gence/following-up-on-follow-on-biologics/77899951/?kwrd=top%2020%20of%202013.
10. Amgen Inc. Letter to Shareholders [Internet]. 2013 [cited 2014 Jan 1]. Available from: http://wwwext.amgen.com/pdfs/investors/Investors_2012_AnnualReport.pdf.
11. Amgen Inc. Amgen Biosimilars [Internet]. 2014. Available from: http://www.amgen.com/science/amgen_biosi-milars_pioneer.html.
12. Administration AGD of HTG. Evaluation of biosimilars: Naming conventions for biosimilars [Internet]. [cited 2014 Jan 2]. Available from: http://www.tga.gov.au/industry/pm-arg-pm-biosimilars-10.htm#.UsVNI1vuL5w.
13. Administration AGD of HTG. Evaluation of biosimilars: Labels, product information (PI) and consumer medicine information (CMI) for biosimilars [Internet]. [cited 2014 Jan 2]. Available from: http://www.tga.gov.au/industry/pm-argpm-bio-similars-11.htm#.UsVN7lvuL5w.
14. EMA. Inflectra: EPAR - Product Information [Internet]. 2013. Available from: http://www.ema.europa.eu/docs/cs_CZ/document_library/EPAR_-_Product_Information/hu-man/002778/WC500151489.pdf.
15. SÚKL. Rozhodnutí SÚKL Sukl176313/2013 [Internet]. 2013 [cited 2014 Jan 2]. Available from: http://www.sukl.cz/modu-les/procedures/doc.php?id=118676488.