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Biosimilar medicines and patient registries – expectations, limitations, and opportunities

,  oraz    | 20 lut 2018

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1. Pec J, Chromej I, Martinaskova K, Chribikova I, Danilla T, Adamicova K, Babal P, Fetisovova Z, Frlickova Z, Lidaj J, Masarovicova A, Minarikova E, Musak L, Osusky P, Pec M, Plank L, Vodicka P, Hegyi V. Chronicka loziskova psoriaza: komplexny pohlad na problematiku a biologicka liecba. 1. vydanie. Banská Bystrica: Dali; 2006.Search in Google Scholar

2. Pec J, Urbancek S, Martinaskova K, Simaljakova M, Osusky P, Adamicova K, Adamovicova K, Adamkov M, Babal P, Cerkalova I, Fetisovova Z, Holy B, Chribikova I, Chromy Stefan, Kubatka P, Mensikova J, Mitterova V, Nejdkova A, Pajerchin D, Pec J jr., Pec M, Rasochova E, Stracenska J, Vrtikova E, Zaujec L. Liecba psoriazy acitretinom. 1. vydanie. Bratislava: Univerzita Komenského; 2007.Search in Google Scholar

3. European Medicines Agency, “http://www.ema.europa.eu,” [Online]. Available: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2014/10/WC500176768.pdf. [Accessed 28 november 2017].Search in Google Scholar

4. U.S. Food and drug administration, “www.fda.gov,” [Online]. Available: https://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/Biosimilars/ucm580419.htm#biosimilar. [Accessed 29 november 2017].Search in Google Scholar

5. Crommelin D, de Vliger J, Weinstein V, Muhlebach S, Shah V, Schellekens H. Different Pharma ceutical Products Need Similar Terminology. AAPS J 2014; 16(1): 11-14.10.1208/s12248-013-9532-0388952524065599Search in Google Scholar

6. Biosimilar resource center, “www.biosimilarsresourcecenter.org,” [Online]. Available: https://www.-biosimilarsresourcecenter.org/faq/what-is-a-biobetter/. [Accessed 29 november 2017].Search in Google Scholar

7. Halim L, Brinks V, Jiskoot W, Romeijn S, Praditpornsilpa K, Assawamakin A, Schellekens H. How bio-questionable are the different recombinant human erythropoietin copy products in Thailand?. Pharm Res 2014; 31(5): 1210-1218.10.1007/s11095-013-1243-924258097Search in Google Scholar

8. Schenider C. Biosimilars in rheumatology: the wind of change. Ann Rheum Dis 2013; 72(3): 315 - 318.10.1136/annrheumdis-2012-20294123390018Search in Google Scholar

9. Goel N, Chance K. Biosimilars in rheumatology: understanding the rigor of their development. Rheumatology (Oxford) 2017; 56(2): 187-197.10.1093/rheumatology/kew206541092827241704Search in Google Scholar

10. Jahnsen J. Clinical experience with infliximab biosimilar Remsima (CT-P13) in inflammatory bowel disease patients. Therap Adv Gastroenterol 2016; 9(3): 322-329.10.1177/1756283X16636764483010627134662Search in Google Scholar

11. Transparency Market Research, “www.prnewswire.com,” [Online]. Available: https://www.prnewswire.com/news-releases/global-biologics-market-will-be-worth-us479-752-million-by-2024-global-industry-analysis-size-share-growth-trends-and-forecast-2016---2024-tmr-596150181.html. [Accessed 30 november 2017].Search in Google Scholar

12. Reuters, “www.reuters.com,” [Online]. Available: https://www.reuters.com/article/us-health-pharmaceuticals-spending/global-prescription-drug-spend-seen-at-1-5-trillion-in-2021-reportidUSKBN13V0CB. [Accessed 30 november 2017].Search in Google Scholar

13. Genetic engineering and Biotechnology news, “www.genengnews.com,” [Online]. Available: https://www.genengnews.com/the-lists/the-top-15-best-selling-drugs-of-2016/77900868. [Accessed 30 november 2017].Search in Google Scholar

14. INESS, “www.cenastatu.sk,” [Online]. Available: http://www.cenastatu.sk/teachers/vvv_full_2016.pdf. [Accessed 29 november 2017].Search in Google Scholar

15. IMS health, “IMS data,” 2016.Search in Google Scholar

16. Forbes, “www.forbes.com,” [Online]. Available: https://www.forbes.com/sites/matthewherper/2013/08/11/the-cost-of-inventing-a-new-drug-98-companies-ranked/#7b5fb3042f08. [Accessed 30 november 2017].Search in Google Scholar

17. Pharmatimes online, “www.pharmatimes.com,” [Online]. Available: http://www.pharmatimes.com/news/over_700_biosimilars_now_in_development_worldwide_report_1002547. [Accessed 30 november 2017].Search in Google Scholar

18. RAPS - Regulatory affairs professionals society, “www.raps.org,” [Online]. Available: http://www.raps.org/Regulatory-Focus/News/2017/03/31/27240/Are-Biosimilars-Interchangeable-in-the-EU-A-New-Perspective/. [Accessed 1 december 2017].Search in Google Scholar

19. Baker M, Reynolds H, Lumicisi B, Bryson C. Immunogenicity of protein therapeutics. Self Nonself 2010; 1(4): 314-322.10.4161/self.1.4.13904306238621487506Search in Google Scholar

20. Danese S, Fiorino G, Raine T, Ferrante M, Kemp K, Kierkus J, Lakatos P, Mantzaris P, van der Woude J, Panes J, Peyrin-Biroulet L. ECCO Position Statement on the Use of Biosimilars for Inflammatory Bowel Disease-An Update. J Crohns Colitis 2017; 11(1): 26-34.10.1093/ecco-jcc/jjw19827927718Search in Google Scholar

21. Cohen H, Beydoun D, Chien D, Lessor T, McCabe D, Muenzberg M, Popovian R, Uy J. Awareness, Knowledge, and Perceptions of Biosimilars Among Specialty Physicians. Adv Ther 2017; 33(12): 2160-2172.10.1007/s12325-016-0431-5512618727798772Search in Google Scholar

22. Alten R, Cronstein B. Clinical trial development for biosimilars. Semin Arthritis Rheum 2015; 44(6): Suppl S2-8.10.1016/j.semarthrit.2015.04.00226058550Search in Google Scholar

23. Hallersten A, Furst W, Mezzasalma R. Physicians prefer greater detail in the biosimilar label (SmPC) - Results of a survey across seven European countries. Regul Toxicol Pharmacol 2016; 77: 275-281.10.1016/j.yrtph.2016.03.02127041395Search in Google Scholar

24. Peyrin-Biroulet L, Lonnfors S, Roblin X, Avedano L. Patient Perspectives on Biosimilars: A Survey by the European Federation of Crohn's and Ulcerative Colitis Associations. J Crohns Colitis 2017; 11(1): 128-133.10.1093/ecco-jcc/jjw138Search in Google Scholar

25. Danese S, Fiorino G, Michetti P. Viewpoint: knowledge and viewpoints on biosimilar monoclonal antibodies among members of the European Crohn's and Colitis Organization. J Crohns Colitis 2014; 8(11): 1548-1550.10.1016/j.crohns.2014.06.007Search in Google Scholar

26. Danese S, Fiorino G, Michetti P. Changes in Biosimilar Knowledge among European Crohn's Colitis Organization [ECCO] Members: An Updated Survey. J Crohns Colitis 2016; 10(11): 1362-1365.10.1093/ecco-jcc/jjw090Search in Google Scholar

27. Rovensky J, Jurgos L, Pec J. 58. list racionálnej farmakoterapie - Racionálna liečba biologicky podobnými liekmi v indikáciách bioterapeutík. Štandarný diagnostický a terapeutický postup 2013; 16(7): 1-4.Search in Google Scholar

28. Generics and Biosimilars initiative, “http://www.gabionline.net/,” [Online]. Available: http://www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Europe. [Accessed 29 november 2017].Search in Google Scholar

29. U.S. Food and drug administration, “www.fda.gov,” [Online]. Available: https://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/Biosimilars/UCM560162.pdf. [Accessed 1 december 2017].Search in Google Scholar

30. U.S. Food and drug administration, “www.fda.gov,” [Online]. Available: https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm587378.htm. [Accessed 1 december 2017].Search in Google Scholar

31. Khraishi M, Stead D, Lukas M, Scotte F, Schmid H. Biosimilars: A Multidisciplinary Perspective. Clin Ther 2016; 38(5): 1238-1249.10.1016/j.clinthera.2016.02.023Search in Google Scholar

32. European Medicine Agency, “www.ema.europa.eu,” [Online]. Available: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2015/01/WC500180219.pdf. [Accessed 2 december 2017].Search in Google Scholar

33. European Medicine Agency, “www.ema.europa.eu,” [Online]. Available: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Public_assessment_report/human/002576/WC500151486.pdf. [Accessed 2 december 2017].Search in Google Scholar

34. Jorgensen K, Olsen I, Lorentzen M, Bolstad N, Haavardsholm E, Lundin K, Mork C, Jahnsen J, Kvien T, NOR-SWITCH study group. Switching from originator infliximab to biosimilar CT-P13 compared with maintained treatment with originator infliximab (NOR-SWITCH): a 52-week, randomised, double-blind, non-inferiority trial. Lancet 2017; 389(10086): 2304-2316.10.1016/S0140-6736(17)30068-5Search in Google Scholar

35. Healio Gastroenterology, “www.healio.com,” [Online]. Available: https://www.healio.com/gastroenterology/inflammatory-bowel-disease/news/online/%7B10599c7d-b5ee-4646-b4c1-59dc1a0b918b%7D/nor-switch-switching-to-remicade-biosimilar-safe-noninferior. [Accessed 3 december 2017].Search in Google Scholar

36. Kay J, Schoels M, Dorner T, Emery P, Kvien T, Smolen J, Breedveld F, Biosimilars to treat rheu diseases task force. Consensus-based recommendations for the use of biosimilars to treat rheumatological diseases. Ann Rheum Dis 2017, no. pii: annrheumdis-2017-211937. doi: 10.1136/annrheumdis-2017-211937. [Epub ahead of print].10.1136/annrheumdis-2017-21193728866648Search in Google Scholar

37. PubMed Health, “www.ncbi.nlm.nih.gov,” [Online]. Available: https://www.ncbi.nlm.nih.gov/pubmedhealth/PMH0095881/. [Accessed 3 december 2017].Search in Google Scholar

38. Fleischmann R. Therapy: Biosimilars in rheumatology - why, how and when in 2017. Nat Rev Rheumatol 2017; 13(12): 701-703.10.1038/nrrheum.2017.17929097811Search in Google Scholar

39. Moots R, Azevedo V, Coindreau J, Dorner T, Mahqoub E, Mysler E, Scheinberg M, Marshall L. Switching Between Reference Biologics and Biosimilars for the Treatment of Rheumatology, Gastroenterology, and Dermatology Inflammatory Conditions: Considerations for the Clinician. Curr Rheumatol Rep 2017; 19(37): 1-16.10.1007/s11926-017-0658-4548659528623625Search in Google Scholar

40. Glintborg B, Sorensen I, Loft A, Lindegaard H, Linauskas A, Hendricks O, Hansen I, Jensen D, Manilo N, Espesen J, Klarlund M, Grydehoj J, Dieperink S, Kristensen S, Olsen J, Nordin H, Chrysidis S, Dalsgaard Pedersen D, Sorensen M, Andersen L, Gron K, Krogh N, Pedersen L, Hetland M. A nationwide non-medical switch from originator infliximab to biosimilar CT-P13 in 802 patients with inflammatory arthritis: 1-year clinical outcomes from the DANBIO registry. Ann Rheum Dis 2017; 76(8): 1426-1431.10.1136/annrheumdis-2016-21074228473425Search in Google Scholar

41. Glintborg B, Sorensen I, Loft A, Heltand M. FRI0190 Clinical outcomes from a nationwide nonmedical switch from originator to biosimilar etanercept in patients with inflammatory arthritis after 5 months follow-up. Results from the danbio registry. in Conference Paper: Annual European Congress of Rheumatology, 2017.10.1136/annrheumdis-2017-eular.1703Search in Google Scholar

42. Kim W, Buske C, Oqura M, Jurczak W, Sancho J, Zhavrid E, Kim J, Hernandez-Rivas J, Prokharau A, Vasilica M, Nagarkar R, Osmanov D, Kwak L, Lee S, Lee S, Bae Y, Coiffier B. Efficacy, pharmacokinetics, and safety of the biosimilar CT-P10 compared with rituximab in patients with previously untreated advanced-stage follicular lymphoma: a randomised, double-blind, parallel-group, non-inferiority phase 3 trial. Lancet Haematol 2017; 4(8): e362-e373. doi: 10.1016/S2352-3026(17)30120-5. Epub 2017 Jul 14.Search in Google Scholar

43. Jurczak W, Moreira I, Kanakasetty G, Munhoz E, Echeveste M, Giri P, Castro N, Pereira J, Akria L, Alexeev S, Osmanov E, Zhu P, Alexandrova S, Zubel A, Harlin O, Amersdorffer J. Rituximab biosimilar and reference rituximab in patients with previously untreated advanced follicular lymphoma (ASSIST-FL): primary results from a confirmatory phase 3, double-blind, randomised, controlled study. Lancet Haematol 2017; 4(8): e350-e361. doi: 10.1016/S2352-3026(17)30106-0. Epub 2017 Jul 14.Search in Google Scholar

44. Missouri State Tumor Registrars Association - MOSTRA, “https://mostra-ctr.org,” [Online]. Available: https://mostra-ctr.org/AboutUs/RegistrarsandOurCode/TheOriginoftheCancerRegistry/tabid/145/Default.aspx.[Accessed 3 december 2017].Search in Google Scholar

45. Ondrusova M. Narodny onkologicky register Slovenskej republiky - zakladny zdroj informacii v zdravotnickej politike. Onkologia (Bratisl.) 2006; 1: 64-65.Search in Google Scholar

46. NCZI - Narodne centrum zdravotnickych informacii, “http://www.nczisk.sk,” [Online]. Available: http://www.nczisk.sk/Publikacie/Pages/Edicia-analytickych-publikacii.aspx. [Accessed 3 december 2017].Search in Google Scholar

47. Pec J, Martinaskova K, Valentova V, Vorcakova K, Adamicova K, Urbancek S, Lipovsky P, Baloghova J, Drotarova K, Fetisovova Z, Hemza M, Chribikova I, Jautova J, Lidaj J, Linkeschova E, Masarovicova A, Osusky P, Palotai T, Pec M, Pecova K, Polak I, Psotova M, Surnakova K, Salkovska J, Svec J, Simaljakova M, Tindirova M, Vojtas I, Zaujec L. Systemova liecba psoriazy u dospelych. 1. vydanie. Bratislava: Univerzita Komenskeho; 2010.Search in Google Scholar

48. Gliklich R, Dreyer N. Registries for evaluating outcomes: User´s guide. 2 ed. Rockville, MD; Agency for Healthcare Research and quality; 2010.Search in Google Scholar

49. Sokka T, Krishnan E, Hakkinen A, Hannonen P. Functional disability in rheumatoid arthritis patients compared with a community population in Finland. Arthritis Rheum 2003; 48(1): 59-63.10.1002/art.1073112528104Search in Google Scholar

50. Kvien T, Uhlig T. The Oslo experience with arthritis registries. Clin Exp Rheumatol 2003; 21(5 Suppl 31): S118-122.Search in Google Scholar

51. Silman A, Klareskog L, Breedveld F, Bresnihan B, Maini R, Van Riel P, Symmons D. Proposal to establish a register for the long term surveillance of adverse events in patients with rheumatic diseases exposed to biological agents: the EULAR Surveillance Register for Biological Compounds. Ann Rheum Dis 2000; 59(6): 419-420.10.1136/ard.59.6.419175317010834856Search in Google Scholar

52. Mariette X, Gottenberg J, Ravaud P, Combe B. Registries in rheumatoid arthritis and autoimmune diseases: data from the French registries. Rheumatology (Oxford) 2011; 50(1): 222-229.10.1093/rheumatology/keq36821148156Search in Google Scholar

53. Hetland M, Unkerskov J, Ravn T, Friis M, Tarp U, Andersen L, Petri A, Khan H, Stenver D, Hansen A, Ostergaard M. Routine database registration of biological therapy increases the reporting of adverse events twentyfold in clinical practice. First results from the Danish Database (DANBIO). Scand J Rheumatol 2005; 34(1): 40-44.10.1080/0300974051001796815903024Search in Google Scholar

54. Elkayam O, Pavelka K. Biologic registries in rheumatology: lessons learned and expectations for the future. Autoimmun Rev 2012; 12(2): 329-33610.1016/j.autrev.2012.05.00922683382Search in Google Scholar

55. Alrubairy L, Rikaby I, Hutchings H, Williams J. Can the inflammatory bowel disease biologics registry lead to improved quality of care?. Journal of Taibah University Medical Sciences 2015; 10(3): 373-375.10.1016/j.jtumed.2015.02.008Search in Google Scholar

56. Markman M. Maurie Markman on the Groundbreaking TAPUR Trial. Oncology (Williston Park) 2017; 31(3): 158-168.Search in Google Scholar

57. Gladman D, Ritchlin C, Helliwell P. Psoriatic arthritis clinical registries and genomics. Ann Rheum Dis 2005; 64(Suppl 2): 103-105.10.1136/ard.2004.030973176685815708920Search in Google Scholar

58. European Medicines Agency, “http://www.ema.europa.eu,” [Online]. Available: http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/q_and_a/q_and_a_detail_000037.jsp&mid=WC0b01ac0580023e7a. [Accessed 3 december 2017].Search in Google Scholar

59. Elder J. Psoriasis clinical registries, genetics, and genomics. Ann Rheum Dis 2017; 64(Suppl 2): 106-107.10.1136/ard.2004.030833176687015708921Search in Google Scholar

60. Struve C. The FDA and the tort system: postmarketing surveillance, compensation, and the role of litigation. Yale J Health Policy Law Ethics 2005; 5(2): 587-669.Search in Google Scholar

61. Garattini S, Bertele V. How can we regulate medicines better?. BMJ 2007; 335(7624): 803-805.10.1136/bmj.39281.615706.94203474317947785Search in Google Scholar

62. Zink A, Askling J, Dixon W, Klareskog L, Silman A, Symmons D. European biologicals registers: methodology, selected results and perspectives. Ann Rheum Dis 2009; 68(8): 1240-1246.10.1136/ard.2008.09192618647854Search in Google Scholar

63. Steliarova-Foucher E, Colombet M, Ries L, Moreno F, Doyla A, Bray F, Hesseling P, Shin H, Stiller C, IICC-3 contributors. International incidence of childhood cancer, 2001-10: a population-based registry study. Lancet Oncol 2017; 18(6): 719-731.10.1016/S1470-2045(17)30186-9Search in Google Scholar

64. Crocetti E, Buzzoni C. Do big numbers assure high-quality of data?. Lancet Haematol 2017; 4(7): e309. doi: 10.1016/S2352-3026(17)30107-2.10.1016/S2352-3026(17)30107-2Search in Google Scholar

65. Sutka R, Pec J, Pecova T. Centralised biological therapy registry for moderate to severe plaque psoriasis - overview and methodology. Acta Medica Martiniana 2016; 16(1): 36-48.10.1515/acm-2016-0005Search in Google Scholar

66. NCZI - Narodne centrum zdravotnickych informacii, “http://www.nczisk.sk,” [Online]. Available: http://www.nczisk.sk/Registre/Narodne-zdravotne-registre/Pages/default.aspx. [Accessed 3 december 2017].Search in Google Scholar

67. Pavelka K, Sedova L, Hejduk K, Dusek L. 15 years experience with biological therapy of inflammatory rheumatic diseases in Czech national register ATTRA. Cas Lek Cesk 2016; 155(6): 285-293.Search in Google Scholar

68. Kojanova M, Fialova J, Cetkovska P, Gkalpakiotis S, Jircikova J, Dolezal T, Arenberger P, Skupina Biorep. Analýza pacientů se středně těžkou až těžkou psoriázou před zahájením biologické léčby v České republice - údaje z registru BIOREP 2005-2016. Ces-slov Derm 2016; 91(5): 223-232.Search in Google Scholar

69. Czech National Cancer Registry (CNCR), “http://www.uzis.cz,” [Online]. Available: http://www.uzis.cz/en/registers/national-health-registers/czech-national-cancer-registry. [Accessed 3 december 2017].Search in Google Scholar

70. CREDIT-Cesky registr IBD pacientu na biologicke lecbe, “http://credit.registry.cz,” [Online]. Available: http://credit.registry.cz/index-en.php?pg=participating-centres. [Accessed 3 december 2017].Search in Google Scholar

71. Ministry of Health of Slovak Republic, “http://www.health.gov.sk,” [Online]. Available: http://www.health.gov.sk/?strategia-v-zdravotnictve. [Accessed 12 január 2018].Search in Google Scholar

eISSN:
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Język:
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Dziedziny czasopisma:
Medicine, Clinical Medicine, Internal Medicine, Cardiology