Biosimilars in dermatology: Starting with infliximab;Biosimilares en dermatología: infliximab para empezar

Actas Dermo-Sifiliograficas

Volumn 104, Issue 3, 2013, Pages 175-180

  Puig, L ^a  

^a UNIVERSITAT AUTÒNOMA DE BARCELONA   (Spain)

Author keywords

[No Author keywords available]

Indexed keywords

BIOSIMILAR AGENT; INFLIXIMAB;

DERMATOLOGY; REVIEW;

EID: 84876517355     PISSN: 00017310     EISSN: 15782190     Source Type: Journal    
DOI: 10.1016/j.ad.2012.10.002     Document Type: Article

References (33)

1. [consultado 8 Oct 2012]. Disponible en: http://beeserlaw.ca/2012/07/24/ celltrion-announces-korean-approval-of-biosimilar-monoclonal-antibody/
2. Beeser S. Celltrion announces Korean approval of biosimilar monoclonal antibody [consultado 8 Oct 2012]. Disponible en: http://www.abstracts2view.com/ eular/search.php?search=do &intMaxHits=10&where%5B%5D= &andornot%5B%5D=&query=CTP13
3. Manchanda V, Vijayakannan R, Mehta R. Merck - Celltrion filed first mAB Biosimilar in Europe: Remicade Challenged [consultado 8 Oct 2012]. Disponible en: http://www.mpadvisor. com/abstractdetails.aspx?id=2195
4. European Medicines Agency. Applications for new human medicines under evaluation by the Committee for Medicinal Products for Human Use [consultado 8 Oct 2012]. Disponible en: http://www.ema.europa.eu/docs/en GB/document library/Report/2012/08/WC500130621.pdf
5. Anónimo. Dr Reddy's plans EU launch for biosimilar rituximab [consultado 8 Oct 2012]. Disponible en: http://www. gabionline.net/Biosimilars/ News/Dr-Reddy-s-plans-EU-launchfor- biosimilar-rituximab
6. Biosimilar News. Dr. Reddy's and Merck Serono to develop and commercialise biosimilars [consultado 8 Oct 2012]. Disponible en: http://www.biosimilarnews.com/dr-reddys-andmerck- serono-to-develop-and- commercialise-biosimilars
7. BCC Research. Biologic Therapeutic Drugs: Technologies and Global Markets [consultado 8 Oct 2012]. Disponible en: http://www.bccresearch.com/report/ biologic-therapeutic-drugsbio079a. html
8. Dranitsaris G, Amir E, Dorward K. Biosimilars of biological drug therapies: regulatory, clinical and commercial considerations. Drugs. 2011;71: 1527-36.
9. Park SS, Park J, Ko J, Chen L, Meriage D, Crouse-Zeineddini J, et al. Biochemical assessment of erythropoietin products from Asia versus US Epoetin alfa manufactured by Amgen. J Pharm Sci. 2009;98: 1688-99.
10. European Medicines Agency. European Medicines Agency finalises guidance on medicines containing monoclonal antibodies [consultado 8 Oct 2012]. Disponible en: http://www.ema. europa.eu/ema/index.jsp?curl=pages/news and events/news/2012/06/news detail 001527.jsp&mid=WC0b01ac058004d5c1
11. U.S. Food and Drug Administration. Biosimilars [consultado 8 Oct 2012]. Disponible en: http://www.fda.gov/Drugs/DevelopmentApprovalProcess/ HowDrugsareDevelopedand- Approved/ApprovalApplications/TherapeuticBiologic- Applications/Biosimilars/default.htm
12. Schiestl M, Stangler T, Torella C, Cepeljnik T, Toll H, Grau R. Acceptable changes in quality attributes of glycosylated biopharmaceuticals. Nat Biotechnol. 2011;29: 310-2.
13. McCamish M, Woollett G. Worldwide experience with biosimilar development. MAbs. 2011;3: 209-17.
14. McCamish M, Woollett G. The state of the art in the development of biosimilars. Clin Pharmacol Ther. 2012;91: 405-17.
15. Roger SD. Biosimilars: current status and future directions. Expert Opin Biol Ther. 2010;10: 1011-8.
16. Reichert JM, Beck A, Iyer H. European Medicines Agency workshop on biosimilar monoclonal antibodies: July 2, 2009, London, UK. MAbs. 2009;1: 394-416.
17. Wiatr C. US biosimilar pathway unlikely to be used: developers will opt for a traditional BLA filing. BioDrugs. 2011;25: 63-7.
18. Scheinberg MA, Kay J. The advent of biosimilar therapies in rheumatology-O brave new world. Nat Rev Rheumatol. 2012;8: 430-6.
19. Bill of the House of Representatives H.R. 3590 [consultado 8 Oct 2012]. Disponible en: http://www.fda.gov/downloads/Drugs/ GuidanceComplianceRegulatoryInformation/UCM216146.pdf
20. GaBI Online - TNF biosimilar approved in China [consultado 8 Oct 2012]. Disponible en: http://gabionline.net/Biosimilars/News/TNF-biosimilar-approved- in-China
21. Elsevier Business Intelligence. Hanwha Files For Korea Approval For Biosimilar Of Amgen's Enbrel [consultado 8 Oct 2012]. Disponible en: http://www.bioportfolio.com/news/article/1163645/Hanwha-Files-For-Korea- Approval-For-Biosimilar-Of- Amgen-s-Enbrel.html
22. GaBI Online - Daiichi Sankyo and Coherus BioSciences make biosimilars deal Posted 18/05/2012 [consultado 8 Oct 2012]. Disponible en: http://www.gabionline.net/layout/set/print/content/view/full/1902
23. Clinical trials Feeds. Pharmacokinetics and Safety Study of BI 695501 in Healthy Subjects [consultado 8 Oct 2012]. Disponible en: http:// clinicaltrialsfeeds.org/clinicaltrials/show/NCT01505491
24. GaBI Online - Brazil to manufacture biosimilar adalimumab [consultado 8 Oct 2012]. Disponible en: http://gabionline.net/Biosimilars/News/Brazil-to- manufacture-biosimilaradalimumab
25. Fujifilm Corporation. Establishment of Fujifilm Kyowa Kirin Biologics. Joint-Venture of Fujifilm and Kyowa Hakko Kirin for the development, manufacturing and sales of biosimilars [consultado 8 Oct 2012]. Disponible en: http://www. fujifilm.com/news/n120327.html
26. GaBI Online - US$54 billion worth of biosimilar patents expiring before 2020 [consultado 8 Oct 2012]. Disponible en: http://www.gabionline.net/ Biosimilars/Research/US-54-billion -worth-of-biosimilar-patents-expiring-before- 2020
27. GENNewsHighlights. Abbott Expects Spinoff AbbVie to Be a $17.4B Proprietary Drug-CMO Powerhouse [consultado 8 Oct 2012]. Disponible en: http://www.genengnews.com/gen-newshighlights/abbott-expects-spinoff-abbvie-to- be-a-17-4bproprietary- drug/81246872/
28. The United States Patent and Trademark Office [consultado 8 Oct 2012]. Disponible en: http://www.uspto.gov/patents/resources/terms/156.jsp
29. GaBI Online - Abbott asks FDA to block adalimumab biosimilar Posted 04/05/2012 [consultado 8 Oct 2012]. Disponible en: http://www.gabionline.net/ layout/set/print/content/view/full/1884
30. Daghlian M. Amgen Issued New Patent on RA Drug Enbrel [consultado 8 Oct 2012]. Disponible en: http://www.burrillreport. com/article-4106.html
31. Lim JJH, Choi AY. Samsung takes first step into biosimilar market [consultado 8 Oct 2012]. Disponible en: http://www. kimchang.com/mailzine.asp? mailzine no=893
32. Palmer E. Samsung says its manufacturing 'DNA' will provide big biosimilar savings [consultado 8 Oct 2012]. Disponible en: http://www. fiercepharmamanufacturing.com/story/samsungsays- its-manufacturing-dna-will- provide-big-biosimilar-savings/2012-04-16
33. Biologic Manufacturing China 2012 [consultado 8 Oct 2012]. Disponible en: http://www.giiconference.com/iqpc243588-2012/catalog.pdf