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Volumn 5, Issue 1, 2017, Pages

Supply-side and demand-side policies for biosimilars: an overview in 10 European member states

Author keywords

Biosimilar; policies; pricing; savings; uptake

Indexed keywords


EID: 85056212727     PISSN: None     EISSN: 20016689     Source Type: Journal    
DOI: 10.1080/20016689.2017.1307315     Document Type: Article
Times cited : (46)

References (135)
  • 2
    • 83055163268 scopus 로고    scopus 로고
    • Pharmaceutical policies in European countries in response to the global financial crisis
    • cited, 2016, Jun, 14, Available from
    • Vogler S, Zimmermann N, Leopold C, et al. Pharmaceutical policies in European countries in response to the global financial crisis. South Med Rev. 2011;4(2):1–16. [cited 2016 Jun 14]. Available from: http://apps.who.int/medicinedocs/documents/s19046en/s19046en.pdf
    • (2011) South Med Rev , vol.4 , Issue.2 , pp. 1-16
    • Vogler, S.1    Zimmermann, N.2    Leopold, C.3
  • 3
    • 85165723206 scopus 로고    scopus 로고
    • cited, Jun, 14, Available from
    • European Commission. Ageing, Policy. [Internet]. [cited 2016 Jun 14]. Available from: http://ec.europa.eu/health/ageing/policy/index_en.htm
    • (2016) Ageing, Policy. [Internet
  • 4
    • 85163119458 scopus 로고    scopus 로고
    • cited, 2016, Jun, 14, Available from
    • European Commission. The 2014 EU Summit on chronic diseases. [Internet]. 2014. [cited 2016 Jun 14]. Available from: https://ec.europa.eu/digital-agenda/en/news/eu-summit-how-address-chronic-diseases-europe
    • (2014) The 2014 EU Summit on chronic diseases. [Internet
  • 8
  • 11
    • 85165699584 scopus 로고    scopus 로고
    • cited, 2016, Jun, 14, Available from
    • EMA website. Omnitrope. [Internet]. 2016. [cited 2016 Jun 14]. Available from: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/000607/human_med_000946.jsp&mid=WC0b01ac058001d124
    • (2016) Omnitrope. [Internet
  • 12
    • 84937001758 scopus 로고    scopus 로고
    • Oct, Available from, cited 2016 Jun 14
    • IMS Health. Assessing biosimilar uptake and competition in European markets. [Internet]. 2014 Oct. Available from: https://www.imshealth.com/files/web/IMSH%20Institute/Healthcare%20Briefs/Assessing_biosimilar_uptake_and_competition_in_European_markets.pdf (cited 2016 Jun 14)
    • (2014) Assessing biosimilar uptake and competition in European markets. [Internet
  • 13
    • 85165698637 scopus 로고    scopus 로고
    • cited, Jun, 14, Available from
    • European Medicines Agency website Medicines. [Internet]. [cited 2016 Jun 14]. Available from: http://www.ema.europa.eu/ema/index.jsp?curl=pages%2Fmedicines%2Flanding%2Fepar_search.jsp&mid=WC0b01ac058001d124&searchTab=searchByAuthType&alreadyLoaded=true&isNewQuery=true&status=Authorised&keyword=Enter+keywords&searchType=name&taxonomyPath=&treeNumber=&searchGenericType=biosimilars&genericsKeywordSearch=Submit
    • (2016) website Medicines. [Internet
  • 14
    • 85011861771 scopus 로고    scopus 로고
    • cited, Jun, 14, Available from
    • The WHO Collaborating Centre for Pricing and Reimbursement Policies. Glossary. [Internet]. [cited 2016 Jun 14]. Available from: http://whocc.goeg.at/Glossary/PreferredTerms/
    • (2016) Glossary. [Internet
  • 15
    • 84874824355 scopus 로고    scopus 로고
    • The impact of pharmaceutical pricing and reimbursement policies on generics uptake: implementation of policy options on generics in 29 European countries–an overview
    • cited, 2016, Jun, 14, Available from
    • Vogler S. The impact of pharmaceutical pricing and reimbursement policies on generics uptake: implementation of policy options on generics in 29 European countries–an overview. Gabi J. 2012;1(2):93–100. [cited 2016 Jun 14]. Available from: http://gabi-journal.net/wp-content/uploads/GaBIJ-2012-2-p93-100-SpecialReport-Vogler.pdf
    • (2012) Gabi J , vol.1 , Issue.2 , pp. 93-100
    • Vogler, S.1
  • 16
    • 85165723066 scopus 로고    scopus 로고
    • Nov, cited 2016 Jun 14, Available from
    • IMS Health. The Impact of Biosimilar Competition. [Internet]. 2015 Nov. [cited 2016 Jun 14]. Available from: http://ec.europa.eu/growth/tools-databases/newsroom/cf/itemdetail.cfm?item_type=251&lang=en&item_id=8602
    • (2015) The Impact of Biosimilar Competition. [Internet
  • 17
    • 85153541951 scopus 로고    scopus 로고
    • Key drivers for market penetration of biosimilars in Europe
    • Rémuzat C, Dorey J, Cristeau O, et al. Key drivers for market penetration of biosimilars in Europe. J Mark Access Health Policy. 2017;5(1):1272308.
    • (2017) J Mark Access Health Policy , vol.5 , Issue.1 , pp. 1272308
    • Rémuzat, C.1    Dorey, J.2    Cristeau, O.3
  • 18
    • 85165682056 scopus 로고    scopus 로고
    • Guideline on similar biological medicinal products
    • Oct, 30, cited 2016 Jun 14, Available from
    • EMA (EMEA). Guideline on similar biological medicinal products. CHMP/437/04. [Internet]. 2005 Oct 30. [cited 2016 Jun 14]. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003517.pdf
    • (2005) CHMP/437/04. [Internet
  • 19
    • 85008259058 scopus 로고    scopus 로고
    • What pricing and reimbursement policies to use for off-patent biologicals?–Results from the EBE 2014 biological medicines policy survey
    • cited, 2016, Jun, 14, Available from
    • Acha V, Allin P, Bergunde S, et al. What pricing and reimbursement policies to use for off-patent biologicals?–Results from the EBE 2014 biological medicines policy survey. Gabi J. 2015;4(1):17–24. [cited 2016 Jun 14]. Available from: http://gabi-journal.net/wp-content/uploads/GaBIJ-2015-1-p17-24-OriginalResearch-EBE.pdf
    • (2015) Gabi J , vol.4 , Issue.1 , pp. 17-24
    • Acha, V.1    Allin, P.2    Bergunde, S.3
  • 20
    • 84909962779 scopus 로고    scopus 로고
    • Apr, cited, 2016 Jun 14, Available from
    • Delcroix Lopes S, Marty C, Berdai D. PHIS Pharma Profile France. [Internet]. 2011 Apr. [cited: 2016 Jun 14]. Available from: http://whocc.goeg.at/Literaturliste/Dokumente/CountryInformationReports/PHIS_Pharma%20Profile%20FR_2011_final.pdf
    • (2011) PHIS Pharma Profile France. [Internet
    • Delcroix Lopes, S.1    Marty, C.2    Berdai, D.3
  • 21
    • 84901680637 scopus 로고    scopus 로고
    • Biosimilar granulocyte colony-stimulating factor uptakes in the EU-5 markets: a descriptive analysis
    • Bocquet F, Paubel P, Fusier I, et al. Biosimilar granulocyte colony-stimulating factor uptakes in the EU-5 markets: a descriptive analysis. Appl Health Econ Health Policy. 2014;12(3):315–326.
    • (2014) Appl Health Econ Health Policy , vol.12 , Issue.3 , pp. 315-326
    • Bocquet, F.1    Paubel, P.2    Fusier, I.3
  • 22
    • 85165694338 scopus 로고    scopus 로고
    • Are EU payers adapting biosimilar pricing and reimbursement approval processes to optimize healthcare savings?
    • May, 16-20, Philadelphia, PA, USA: cited 2016 Jun 14, Available from
    • Foxon G, Fox G, Craddy P. Are EU payers adapting biosimilar pricing and reimbursement approval processes to optimize healthcare savings? ISPOR 20th Annual International Meeting; 2015 May 16-20; Philadelphia, PA, USA. [cited 2016 Jun 14]. Available from: http://www.ispor.org/research_pdfs/49/pdffiles/PHP106.pdf
    • (2015) ISPOR 20th Annual International Meeting
    • Foxon, G.1    Fox, G.2    Craddy, P.3
  • 24
    • 85165666134 scopus 로고    scopus 로고
    • Biosimilars entry and price development in Europe
    • Nov, 7–11, Milan, Italy: cited, 2016 Jun 14, Available from
    • Dacheva E, Plich A, Torvinen S. Biosimilars entry and price development in Europe; ISPOR 18th Annual European Congress; 2015 Nov 7–11; Milan, Italy. [cited 2016 Jun 14]. Available from: http://www.ispor.org/research_pdfs/51/pdffiles/PHP99.pdf
    • (2015) ISPOR 18th Annual European Congress
    • Dacheva, E.1    Plich, A.2    Torvinen, S.3
  • 25
    • 85165616851 scopus 로고    scopus 로고
    • cited, Jun, 14, Available from
    • WHO Collaborating Centre for Drug Statistics Methodology. Structure and principles. [Internet]. [cited: 2016 Jun 14]. Available from: http://www.whocc.no/atc/structure_and_principles/
    • (2016) Structure and principles. [Internet
  • 26
    • 85165688040 scopus 로고    scopus 로고
    • Creativ-Ceutical internal proprietary database.
  • 28
    • 84924709591 scopus 로고    scopus 로고
    • Biosimilaires: de la technique au médicoéconomique
    • cited, 2016, Jun, 14, Available from
    • Girault D, Trouvin J-H, Blachier-Poisson C, et al. Biosimilaires: de la technique au médicoéconomique. Thérapie. 2015;70(1):37–46. [cited 2016 Jun 14]. Available from: http://www.journal-therapie.org/articles/therapie/pdf/2015/01/therapie140033.pdf
    • (2015) Thérapie , vol.70 , Issue.1 , pp. 37-46
    • Girault, D.1    Trouvin, J.-H.2    Blachier-Poisson, C.3
  • 29
    • 85165655668 scopus 로고    scopus 로고
    • cited, Jun, 14, Available from
    • Polish Reimbursement Act. Dz.U. 2011 Nr 122 poz. 696. [Internet]. [cited 2016 Jun 14]. Available from: http://isap.sejm.gov.pl/DetailsServlet?id=WDU20111220696
    • (2016) Dz.U. 2011 Nr 122 poz. 696. [Internet
  • 30
    • 85165652880 scopus 로고    scopus 로고
    • cited, 2016, Jun, 14, Available from
    • NICE. NICE’s biosimilars position statement. [Internet]. 2015. [cited 2016 Jun 14]. Available from: https://www.nice.org.uk/Media/Default/About/what-we-do/NICE-guidance/NICE-technology-appraisals/biosimilars-statement.pdf
    • (2015) NICE’s biosimilars position statement. [Internet
  • 31
    • 85165633646 scopus 로고    scopus 로고
    • Sep, 24, cited, 2016 Jun 14, Available from
    • NHS England, Medical Directorate; What is a biosimilar medicine? Guide. [Internet]. 2015 Sep 24. [cited 2016 Jun 14]. Available from: https://www.england.nhs.uk/wp-content/uploads/2015/09/biosimilar-guide.pdf
    • (2015) Guide. [Internet
  • 32
    • 85165682133 scopus 로고    scopus 로고
    • Aug, cited 2016 Jun 14, Available from
    • NICE. Biosimilar medicines –NICE’s approach. [Internet]. 2016 Aug. [cited 2016 Jun 14]. Available from: https://www.nice.org.uk/Media/Default/About/what-we-do/NICE-guidance/NICE-technology-appraisals/Biosimilar-medicines-public-information-aug-16.pdf
    • (2016) Biosimilar medicines –NICE’s approach. [Internet
  • 34
    • 85165628663 scopus 로고    scopus 로고
    • May, cited 2016 Jun 14, Available from
    • SMC website. Biosimilar Medicines. [Internet]. 2015 May. [cited 2016 Jun 14]. Available from: http://www.scottishmedicines.org.uk/About_SMC/Policy_statements/Biosimilar_Medicines
    • (2015) Biosimilar Medicines. [Internet
  • 35
    • 85165649401 scopus 로고    scopus 로고
    • Oct, 21, cited, 2015 Nov, Available from
    • Linton S. Draft minutes of the AWMSG meeting. [Internet]. 2015 Oct 21. [cited 2015 Nov]. Available from: http://www.awmsg.org/docs/awmsg/awmsgdocs/AWMSG%20meetings/2015/Nov%2015/AWMSG%20minutes%20Oct%2015.pdf
    • (2015) Draft minutes of the AWMSG meeting. [Internet
    • Linton, S.1
  • 36
    • 84955255418 scopus 로고    scopus 로고
    • Postmarket policy considerations for biosimilar oncology drugs
    • Renwick MJ, Smolina K, Gladstone EJ, et al. Postmarket policy considerations for biosimilar oncology drugs. Lancet Oncol. 2016;17(1):e31–e8.
    • (2016) Lancet Oncol , vol.17 , Issue.1 , pp. e31-e8
    • Renwick, M.J.1    Smolina, K.2    Gladstone, E.J.3
  • 37
    • 84900828393 scopus 로고    scopus 로고
    • Italy’s final position paper on biosimilars and new price and reimbursement pathway
    • cited, 2016, Jun, 14, Available from
    • Casadei G. Italy’s final position paper on biosimilars and new price and reimbursement pathway. Gabi J. 2013;2(3):106–107. [cited 2016 Jun 14]. Available from: http://gabi-journal.net/italys-final-position-paper-on-biosimilars-and-new-price-and-reimbursement-pathway.html
    • (2013) Gabi J , vol.2 , Issue.3 , pp. 106-107
    • Casadei, G.1
  • 38
    • 85165683780 scopus 로고    scopus 로고
    • Criteri di individuazione degli scaglioni per la negoziazione automatica dei generici e dei biosimilari
    • 4, April, cited 2016 Jun 14, Available form
    • Italian Ministry of Health. Criteri di individuazione degli scaglioni per la negoziazione automatica dei generici e dei biosimilari. Decree 4 April 2013. [cited 2016 Jun 14]. Available form: http://www.gazzettaufficiale.it/atto/serie_generale/caricaDettaglioAtto/originario?atto.dataPubblicazioneGazzetta=2013-06-06&atto.codiceRedazionale=13A04795&elenco30giorni=false
    • (2013) Decree
  • 41
    • 85165663636 scopus 로고    scopus 로고
    • Recent and planned developments in pharmaceutical policies 2016. Special topic: pricing and reimbursement policies for biosimilars
    • Apr, cited, 2016 Jun 14]. Available from
    • Spain. Recent and planned developments in pharmaceutical policies 2016. Special topic: pricing and reimbursement policies for biosimilars. PPRI Poster [Internet]. 2016 Apr. [cited 2016 Jun 14]. Available from: http://whocc.goeg.at/Literaturliste/Dokumente/CountryInformationPosters/ES_Poster_PPRI_Meeting_Lisbon_Apr2016.pdf
    • (2016) PPRI Poster [Internet
  • 42
    • 85165691204 scopus 로고    scopus 로고
    • Aug, 1, cited, 2016 Jun 14, Available from
    • Loi portant des dispositions diverses. Banque Carrefour de la législation [Internet]. 2013 Aug 1. [cited 2016 Jun 14]. Available from: http://www.ejustice.just.fgov.be/cgi/article_body.pl?language=fr&caller=summary&pub_date=13-08-01&numac=2013204390
    • (2013) Banque Carrefour de la législation [Internet
  • 43
    • 85165707402 scopus 로고    scopus 로고
    • cited, Jan, 18, Available from
    • G-BA website. Reference prices and how they are set. [Internet]. [cited 2016 Jan 18]. Available from: ht. tp://www.english.g-ba.de/special-topics/pharmaceuticals/reference/
    • (2016) Reference prices and how they are set. [Internet
  • 44
    • 79957975019 scopus 로고    scopus 로고
    • Tendering for outpatient prescription pharmaceuticals: what can be learned from current practices in Europe?
    • Dylst P, Vulto A, Simoens S. Tendering for outpatient prescription pharmaceuticals: what can be learned from current practices in Europe? Health Policy. 2011;101(2):146–152.
    • (2011) Health Policy , vol.101 , Issue.2 , pp. 146-152
    • Dylst, P.1    Vulto, A.2    Simoens, S.3
  • 47
    • 85165640326 scopus 로고    scopus 로고
    • Tender systems for outpatient pharmaceuticals in the European Union: evidence from the Netherlands, Germany and Belgium
    • Oct, cited 2016 Jun 14, Available from
    • Kanavos P, Seeley E, Vandoros S. Tender systems for outpatient pharmaceuticals in the European Union: evidence from the Netherlands, Germany and Belgium. Eminet report. [Internet]. 2009 Oct. [cited 2016 Jun 14]. Available from: http://ec.europa.eu/health/files/docs/study_pricing_2007/tendering_systems_en.pdf
    • (2009) Eminet report. [Internet
    • Kanavos, P.1    Seeley, E.2    Vandoros, S.3
  • 48
    • 84904023507 scopus 로고    scopus 로고
    • Barriers to the uptake of biosimilars and possible solutions: a belgian case study
    • Dylst P, Vulto A, Simoens S. Barriers to the uptake of biosimilars and possible solutions: a belgian case study. Pharmacoeconomics. 2014;32(7):681–691.
    • (2014) Pharmacoeconomics , vol.32 , Issue.7 , pp. 681-691
    • Dylst, P.1    Vulto, A.2    Simoens, S.3
  • 49
    • 85165678089 scopus 로고    scopus 로고
    • cited, 2016, Jun, 14, Available from ΥΥΑΠΔδΓ ΘΕΜΑ Εγκύκλιος για τα Βιο ομοειδή Φαρμακευτικά προϊόντα
    • οικ.27826 ΥΥΑΠΔδΓ. ΘΕΜΑ: Εγκύκλιος για τα Βιο-ομοειδή Φαρμακευτικά προϊόντα (bio-similars). [Internet]. 2014. [cited 2016 Jun 14]. Available from: https://www.sfee.gr/wp-content/uploads/2014/11/%CE%95%CE%B3%CE%BA%CF%8D%CE%BA%CE%BB%CE%B9%CE%BF%CF%82_%CE%A5%CF%80.%CE%A5%CE%B3%CE%B5%CE%AF%CE%B1%CF%82_%CE%9C%CE%B1%CF%81-2014.pdf
    • (2014) οικ.27826. : - (bio-similars). [Internet
  • 51
    • 85165652697 scopus 로고    scopus 로고
    • cited, 2016, Jun, 14, Available from
    • Polish Public Procurement Law. Dz. U. 2013 poz. 907. [Internet]. [cited 2016 Jun 14]. Available from: http://isap.sejm.gov.pl/DetailsServlet?id=WDU20040190177
    • (2013) poz. 907. [Internet
  • 52
    • 85165642460 scopus 로고    scopus 로고
    • cited, 2016, Jun, 14, Available from
    • Polish Public Finances Law Dz.U. 2009 Nr 157 poz. 1240.[Internet]. [cited 2016 Jun 14]. Available from: http://isap.sejm.gov.pl/DetailsServlet?id=WDU20091571240
    • (2009) Nr 157 poz. 1240.[Internet
  • 53
    • 85165715062 scopus 로고    scopus 로고
    • Impact of market access factors in the adoption of biosimilar anti-TNFs across Europe
    • cited, 2016, Jun, 14, Available from
    • Pinheiro AV, Vithlani M, Sarnataro K, et al. Impact of market access factors in the adoption of biosimilar anti-TNFs across Europe. Precision for Value report. [Internet]. 2016. [cited 2016 Jun 14]. Available from: http://www.precisionforvalue.com/wp-content/uploads/2016/05/Impact-of-Market-Access-Factors-Across-Europe.pdf
    • (2016) Precision for Value report. [Internet
    • Pinheiro, A.V.1    Vithlani, M.2    Sarnataro, K.3
  • 55
    • 84925228929 scopus 로고    scopus 로고
    • Incentives for market penetration of biosimilars in Belgium and in five European countries
    • Swartenbroekx N, Espín J, Gerkens S. Incentives for market penetration of biosimilars in Belgium and in five European countries. J Pharm Belg. 2014;4:38–49.
    • (2014) J Pharm Belg , Issue.4 , pp. 38-49
    • Swartenbroekx, N.1    Espín, J.2    Gerkens, S.3
  • 57
    • 84947215387 scopus 로고    scopus 로고
    • Doctors commitment and long-term effectiveness for cost containment policies: lesson learned from biosimilar drugs
    • Menditto E, Orlando V, Coretti S, et al. Doctors commitment and long-term effectiveness for cost containment policies: lesson learned from biosimilar drugs. Ceor. 2015;7:575–581.
    • (2015) Ceor , vol.7 , pp. 575-581
    • Menditto, E.1    Orlando, V.2    Coretti, S.3
  • 58
    • 84965081890 scopus 로고    scopus 로고
    • How did the introduction of biosimilar filgrastim influence the prescribing pattern of granulocyte colony-stimulating factors? results from a multicentre, population-based study, from five italian centres in the years 2009–2014
    • 30(4):295–306
    • Marcianò I, Ingrasciotta Y, Giorgianni F, et al. How did the introduction of biosimilar filgrastim influence the prescribing pattern of granulocyte colony-stimulating factors? results from a multicentre, population-based study, from five italian centres in the years 2009–2014. BioDrugs. 2016;30(4):295–306.
    • (2016) BioDrugs
    • Marcianò, I.1    Ingrasciotta, Y.2    Giorgianni, F.3
  • 59
    • 84941346467 scopus 로고    scopus 로고
    • How much are biosimilars used in clinical practice? A retrospective Italian population-based study of erythropoiesis-stimulating agents in the years 2009–2013
    • Ingrasciotta Y, Giorgianni F, Bolcato J, et al. How much are biosimilars used in clinical practice? A retrospective Italian population-based study of erythropoiesis-stimulating agents in the years 2009–2013. BioDrugs. 2015;29(4):275–284.
    • (2015) BioDrugs , vol.29 , Issue.4 , pp. 275-284
    • Ingrasciotta, Y.1    Giorgianni, F.2    Bolcato, J.3
  • 61
    • 85165663139 scopus 로고    scopus 로고
    • may, 6, cited, 2016 Jun 14, Available from
    • GaBi website. A strategic approach to increase uptake of biosimilars in Spain [Internet]. 2016 may 6. [cited 2016 Jun 14]. Available from: http://www.gabionline.net/Biosimilars/Research/A-strategic-approach-to-increase-uptake-of-biosimilars-in-Spain
    • (2016) A strategic approach to increase uptake of biosimilars in Spain [Internet
  • 62
    • 85165667040 scopus 로고    scopus 로고
    • Nov, 25, cited 2016 Jun 14, Available from
    • INAMI. Prescrire en DCI: règles pour le pharmacien qui exécute la prescription. [Internet]. 2014 Nov 25. [cited 2016 Jun 14]. Available from: http://www.inami.fgov.be/fr/themes/cout-remboursement/par-mutualite/medicament-produits-sante/delivrer-medicaments/Pages/prescrire-dci-regles-pharmacien-execute-prescription-.aspx#.Vmf08FUrKM8
    • (2014) Prescrire en DCI: règles pour le pharmacien qui exécute la prescription. [Internet
  • 63
    • 85165627407 scopus 로고    scopus 로고
    • cited, 2016, Jun, 14, Available from
    • NHS Business Services Authority. Prescribing budgets. [Internet]. 2015. [cited 2016 Jun 14]. Available from: http://www.nhsbsa.nhs.uk/PrescriptionServices/3996.aspx
    • (2015) Prescribing budgets. [Internet
  • 65
    • 85165719833 scopus 로고    scopus 로고
    • Technology appraisal adoption support. Health technology adoption programme
    • Jul, 31, cited 2016 Sep 14, Available from
    • NICE. Technology appraisal adoption support. Health technology adoption programme. Introducing biosimilar versions of infliximab: Infectra and Remsima.[Internet]. 2015 Jul 31. [cited 2016 Sep 14]. Available from: https://www.nice.org.uk/guidance/ta329/resources/nice-technology-appraisal-adoption-support-for-introducing-biosimilar-versions-of-infliximab-inflectra-and-remsima-639989081845
    • (2015) Introducing biosimilar versions of infliximab: Infectra and Remsima.[Internet
  • 68
    • 85165690707 scopus 로고    scopus 로고
    • Introduction of biosimilar infliximab in the Stockholm region and the Scandinavian experience
    • Apr, 20, cited 2015 Nov,].  Available from
    • Befrits G. Introduction of biosimilar infliximab in the Stockholm region and the Scandinavian experience. Stockholm lans landsting. [Internet]. 2015 Apr 20. [cited 2015 Nov].  Available from: https://ec.europa.eu/commission/index_en
    • (2015) Stockholm lans landsting. [Internet
    • Befrits, G.1
  • 70
    • 84926325514 scopus 로고    scopus 로고
    • Clinical and scientific aspects related to biosimilars in inflammatory bowel diseases (IBD): position document of the Belgian IBD Research & Development Group (BIRD)
    • Vermeire S, Louis E, Dewit O, et al. Clinical and scientific aspects related to biosimilars in inflammatory bowel diseases (IBD): position document of the Belgian IBD Research & Development Group (BIRD). Acta Gastro-Ent Belg. 2015;78(1):26–29.
    • (2015) Acta Gastro-Ent Belg , vol.78 , Issue.1 , pp. 26-29
    • Vermeire, S.1    Louis, E.2    Dewit, O.3
  • 71
    • 85165721793 scopus 로고    scopus 로고
    • Apr, 15, cited 2016 Jun 14, Available from
    • SNFGE. Information sur les infliximab biosimilaires. [Internet]. 2015 Apr 15. [cited 2016 Jun 14]. Available from: http://www.snfge.org/actualite/information-sur-les-infliximab-biosimilaires
    • (2015) Information sur les infliximab biosimilaires. [Internet
  • 72
    • 84947021083 scopus 로고    scopus 로고
    • Position paper from the Spanish Society of Rheumatology on biosimilar drugs
    • Abad Hernández MÁ, Andreu JL, Caracuel Ruiz MÁ, et al. Position paper from the Spanish Society of Rheumatology on biosimilar drugs. Reumatol Clin. 2015;11(5):269–278.
    • (2015) Reumatol Clin , vol.11 , Issue.5 , pp. 269-278
    • Abad Hernández, M.Á.1    Andreu, J.L.2    Caracuel Ruiz, M.Á.3
  • 73
    • 85053506955 scopus 로고    scopus 로고
    • Feb, cited, 2016 Jun 14, Available from
    • BSR. Position statement on biosimilar medicines. [Internet]. 2015 Feb. [cited 2016 Jun 14]. Available from: http://www.rheumatology.org.uk/about_bsr/press_releases/bsr_supports_the_use_of_biolsimilars_but_recommends_measures_to_monitor_safety.aspx#
    • (2015) Position statement on biosimilar medicines. [Internet
  • 74
    • 84922747685 scopus 로고    scopus 로고
    • Biological therapy in inflammatory bowel diseases: access in Central and Eastern Europe
    • Rencz F, Péntek M, Bortlik M, et al. Biological therapy in inflammatory bowel diseases: access in Central and Eastern Europe. World J Gastroenterol. 2015;21(6):1728–1737.
    • (2015) World J Gastroenterol , vol.21 , Issue.6 , pp. 1728-1737
    • Rencz, F.1    Péntek, M.2    Bortlik, M.3
  • 76
    • 85165694666 scopus 로고    scopus 로고
    • Sep, 15, cited 2016 Nov 10, Available from
    • AIFA. Secondo Concept Paper AIFA sui Farmaci Biosimilari. [Internet]. 2016 Sep 15. [cited 2016 Nov 10]. Available from: http://www.agenziafarmaco.gov.it/sites/default/files/Secondo_Concept_Paper_AIFA_BIOSIMILARI.pdf
    • (2016) Secondo Concept Paper AIFA sui Farmaci Biosimilari. [Internet
  • 79
    • 85165660741 scopus 로고    scopus 로고
    • TNF-alpha inhibitors for ankylosing spondylitis and non-radiographic axial spondyloarthritis
    • Feb, 01, cited 2016 Jun 14, Available from
    • NICE. TNF-alpha inhibitors for ankylosing spondylitis and non-radiographic axial spondyloarthritis. Technology appraisal guidance [TA383]. [Internet]. 2016 Feb 01. [cited 2016 Jun 14]. Available from: https://www.nice.org.uk/guidance/ta383/resources/tnfalpha-inhibitors-for-ankylosing-spondylitis-and-nonradiographic-axial-spondyloarthritis-82602848027077
    • (2016) Technology appraisal guidance [TA383]. [Internet
  • 81
    • 85011328910 scopus 로고    scopus 로고
    • Sep, cited 2016 Jun 14, Available from
    • ANSM report. Les médicaments biosimilaires Etat des lieux. [Internet]. 2013 Sep. [cited 2016 Jun 14]. Available from: http://www.ansm.sante.fr/var/ansm_site/storage/original/application/6187b427efca64d2a15e496ff691158e.pdf
    • (2013) Les médicaments biosimilaires Etat des lieux. [Internet
  • 82
    • 85165678718 scopus 로고    scopus 로고
    • May, cited 2016 Jun 14, Available from
    • ANSM report. État des lieux sur les médicaments biosimilaires. [Internet]. 2016 May. [cited 2016 Jun 14]. Available from: http://ansm.sante.fr/var/ansm_site/storage/original/application/c35f47c89146b71421a275be7911a250.pdf
    • (2016) État des lieux sur les médicaments biosimilaires. [Internet
  • 83
    • 85165718381 scopus 로고    scopus 로고
    • Sep, 05, cited 2016 Sep, Available from
    • FAMHP website. Biosimilars. [Internet]. 2016 Sep 05. [cited 2016 Sep]. Available from: http://www.fagg-afmps.be/en/human_use/medicines/medicines/MA_procedures/types/Biosimilars
    • (2016) Biosimilars. [Internet
  • 84
    • 84929506210 scopus 로고    scopus 로고
    • The use of biosimilar drugs in psoriasis: a position paper
    • Hernández GC, Puig L. The use of biosimilar drugs in psoriasis: a position paper. Actas Dermosifiliogr. 2015;4(106):249–251.
    • (2015) Actas Dermosifiliogr , vol.4 , Issue.106 , pp. 249-251
    • Hernández, G.C.1    Puig, L.2
  • 85
    • 84945445313 scopus 로고    scopus 로고
    • Use of biologics for psoriasis in central and eastern European countries
    • Rencz F, Kemény L, Gajdácsi JZ, et al. Use of biologics for psoriasis in central and eastern European countries. Jeadv. 2015;29(11):2222–2230.
    • (2015) Jeadv , vol.29 , Issue.11 , pp. 2222-2230
    • Rencz, F.1    Kemény, L.2    Gajdácsi, J.Z.3
  • 87
    • 85165640728 scopus 로고    scopus 로고
    • Aug, 14, Available from, cited, 2016 Jun 14
    • NRAS. NRAS position paper on biosimilar medicines [Internet]. 2014 Aug 14. Available from: [cited 2016 Jun 14]. http://www.nras.org.uk/data/files/About%20RA/How%20is%20RA%20managed/NRAS%20Biosimilars%20Position%20Paper%20Final.pdf
    • (2014) NRAS position paper on biosimilar medicines [Internet
  • 88
    • 85033370120 scopus 로고    scopus 로고
    • May, 13, cited, 2016 Jun 14, Available from
    • AIFA. Position Paper sui Farmaci Biosimilari. [Internet]. 2013 May 13. [cited 2016 Jun 14]. Available from: http://www.agenziafarmaco.gov.it/sites/default/files/AIFA_POSITION_PAPER_FARMACI_BIOSIMILARI.pdf
    • (2013) Position Paper sui Farmaci Biosimilari. [Internet
  • 89
    • 85165673975 scopus 로고    scopus 로고
    • Available from, cited, 2016, May, 14
    • Biologics in the Polish health system. demosEUROPA. [Internet]. 2015. Available from: http://www.infarma.pl/assets/files/innowacje/Biologics_in_the_Polish_health_system.pdf (cited 2016 May 14)
    • (2015) Biologics in the Polish health system. demosEUROPA. [Internet
  • 90
    • 85013300319 scopus 로고    scopus 로고
    • Apr, 20, Available from, cited 2016 Jun 14
    • PEI. Position of Paul-Ehrlich-Institut regarding the use of biosimilars. [Internet]. 2015 Apr 20. Available from: http://www.pei.de/EN/medicinal-products/antibodies-immunoglobulins-fusion-proteins/monoclonal-antibodies/biosimilars/position-pei-interchangebility-biosimilars-content.html (cited 2016 Jun 14)
    • (2015) Position of Paul-Ehrlich-Institut regarding the use of biosimilars. [Internet
  • 91
    • 84977663507 scopus 로고    scopus 로고
    • Biosimilar drugs-automatic substitution regulations review. Polish ISPOR chapter’s therapeutic programs and pharmaceutical care (TPPC) task force report
    • Drozd M, Szkultecka-Dębek M, Baran-Lewandowska I. Biosimilar drugs-automatic substitution regulations review. Polish ISPOR chapter’s therapeutic programs and pharmaceutical care (TPPC) task force report. Jhpor. 2014;1:52–57.
    • (2014) Jhpor , vol.1 , pp. 52-57
    • Drozd, M.1    Szkultecka-Dębek, M.2    Baran-Lewandowska, I.3
  • 95
    • 85165642589 scopus 로고    scopus 로고
    • cited, 2016, Jun, 14, Available from ΕΦΗΜΕΡΙΣ ΤΗΣ ΚΥΒΕΡΝΗΣΕΩΣ ΤΗΣ ΕΛΛΗΝΙΚΗΣ ΔΗΜΟΚΡΑΤΙΑΣ ΤΕΥΧΟΣ ΔΕΥΤΕΡΟ Αρ Φύλλου
    • ΕΦΗΜΕΡΙΣ ΤΗΣ ΚΥΒΕΡΝΗΣΕΩΣ ΤΗΣ ΕΛΛΗΝΙΚΗΣ ΔΗΜΟΚΡΑΤΙΑΣ ΤΕΥΧΟΣ ΔΕΥΤΕΡΟ Αρ. Φύλλου 64. [Internet]. 2014. [cited 2016 Jun 14]. Available from: http://www.paspama.gr/FEK64B-16-1-14-Plafon.pdf
    • (2014) 64. [Internet
  • 96
    • 84928705954 scopus 로고    scopus 로고
    • Position paper of Italian rheumatologists on the use of biosimilar drugs
    • Atzeni F, Sebastiani M, Ricci C, et al. Position paper of Italian rheumatologists on the use of biosimilar drugs. Clin Exp Rheumatol. 2015;33(1):1–4.
    • (2015) Clin Exp Rheumatol , vol.33 , Issue.1 , pp. 1-4
    • Atzeni, F.1    Sebastiani, M.2    Ricci, C.3
  • 97
    • 85165642649 scopus 로고    scopus 로고
    • cited, 2016, Jun, 14, Available from
    • Läkemedelsverkets. Kriterier för utbytbarhet. [Internet]. 2014. [cited 2016 Jun 14]. Available from: https://lakemedelsverket.se/malgrupp/Halso—sjukvard/Forskrivning/Utbytbara-lakemedel-/Kriterier-for-utbytbarhet/
    • (2014) Kriterier för utbytbarhet. [Internet
  • 98
    • 85165649798 scopus 로고    scopus 로고
    • cited, 2016, Jun, 14, Available from
    • Läkemedelsverkets. Substitutable Medicinal Products. [Internet]. 2015. [cited 2016 Jun 14]. Available from: https://lakemedelsverket.se/upload/halso-och-sjukvard/forskrivning/utbytbarhet/Utbytbara%20l%C3%A4kemedel%20(hela%20listan)%202015-09-30.pdf
    • (2015) Substitutable Medicinal Products. [Internet
  • 99
    • 85165665316 scopus 로고    scopus 로고
    • Apr, 15, cited 2016 Jun 14, Available from
    • INFARMA website. [Internet]. 2015 Apr 15. [cited 2016 Jun 14]. Available from: http://www.infarma.pl/assets/files/innowacje/Leki_biologiczne_leki_nie_do_zastapienia.pdf
    • (2015) INFARMA website. [Internet
  • 100
    • 85165633539 scopus 로고    scopus 로고
    • Apr, 29, cited, 2016 Jun 14, Available form
    • INFARMA letter ZPIFF/90/PSz/2015. [Internet]. 2015 Apr 29. [cited 2016 Jun 14]. Available form: http://www.infarma.pl/assets/files/innowacje/Odpowiedz_INFARMY_na_list_Podsekretarza_Stanu_Igora__Radziewicza-Winnickiego_w_sprawie_lekow_biologicznych.pdf
    • (2015) INFARMA letter ZPIFF/90/PSz/2015. [Internet
  • 101
    • 85165683491 scopus 로고    scopus 로고
    • Apr, 24, cited 2016 Jun 14, Available from
    • Polish Ministry of Health. Letter PLA.4604.199.2015.BRB. [Internet]. 2015 Apr 24. [cited 2016 Jun 14]. Available from: http://www.mz.gov.pl/wp-content/uploads/2015/04/leki-biopodobne-czyste.pdf
    • (2015) Letter PLA.4604.199.2015.BRB. [Internet
  • 102
    • 85165724273 scopus 로고    scopus 로고
    • Apr, 16, cited 2016 Jun 14, Available from
    • GaBi website. Policies and Legislation, UK. [Internet]. 2015 Apr 16. [cited 2016 Jun 14]. Available from: http://www.gabionline.net/Country-Focus/United-Kingdom/Policies-and-Legislation
    • (2015) Policies and Legislation, UK. [Internet
  • 103
    • 85165718381 scopus 로고    scopus 로고
    • Available from, cited, Jun, 14
    • GE website. Biosimilars. [Internet]. Available from: http://www.generikusegyesulet.hu/biosimilar-gyogyszerek/ (cited 2016 Jun 14)
    • (2016) Biosimilars. [Internet
  • 104
    • 85165698477 scopus 로고    scopus 로고
    • Aug, 30, cited 2016 Jun 14, Available from
    • GaBI website. Policies and Legislation, Italy. [Internet]. 2013 Aug 30. [cited 2016 Jun 14]. Available from: http://www.gabionline.net/Country-Focus/Italy/Policies-and-Legislation
    • (2013) Policies and Legislation, Italy. [Internet
  • 106
    • 85023198077 scopus 로고    scopus 로고
    • Sep, 24, cited 2016 Jun 14, Available from
    • National Health Service (NHS) England. What is a biosimilar medicine? [Internet]. 2015 Sep 24. [cited 2016 Jun 14]. Available from: https://www.england.nhs.uk/wp-content/uploads/2015/09/biosimilar-guide.pdf
    • (2015) What is a biosimilar medicine? [Internet
  • 109
    • 85165710857 scopus 로고    scopus 로고
    • cited, 2016, Jun, 14, Available from
    • ProGenerika website. Biosimilars. [Internet]. 2015. [cited 2016 Jun 14]. Available from: http://www.progenerika.de/biosimilars/
    • (2015) Biosimilars. [Internet
  • 110
    • 85165617917 scopus 로고    scopus 로고
    • cited, 2016, Jun, 14, Available from
    • AssoGenerici website. Biosimilari. [Internet]. 2015. [cited 2016 Jun 14]. Available from: http://www.assogenerici.org/2011/biosimilari.asp?s=2&p=1&modulo=biosimilari
    • (2015) Biosimilari. [Internet
  • 111
    • 85165710857 scopus 로고    scopus 로고
    • cited, 2015, Nov, Available form
    • BGMA website. Biosimilars. [Internet]. 2015. [cited 2015 Nov]. Available form: http://www.britishgenerics.co.uk/bgma-key-issues/biosimilars
    • (2015) Biosimilars. [Internet
  • 113
    • 85165617917 scopus 로고    scopus 로고
    • cited, 2015, Nov, Available from
    • FGL website. Biosimilarer. [Internet]. 2015. [cited 2015 Nov]. Available from: http://www.generikaforeningen.se/
    • (2015) Biosimilarer. [Internet
  • 114
    • 85165638139 scopus 로고    scopus 로고
    • cited, 2016, Jun, 14, Available from
    • ProBiosimilars website. [Internet]. 2016. [cited 2016 Jun 14]. Available from: http://probiosimilars.de/
    • (2016) ProBiosimilars website. [Internet
  • 115
    • 85165666580 scopus 로고    scopus 로고
    • cited, 2016, Jun, 14, Available from
    • BBA website. [Internet]. 2016. [cited 2016 Jun 14]. Available from: http://britishbiosimilars.co.uk/hot-topics
    • (2016) BBA website. [Internet
  • 116
    • 84977266172 scopus 로고    scopus 로고
    • cited, 2016, Jun, 14, Available from
    • BioSim website. [Internet]. 2016. [cited 2016 Jun 14]. Available from: http://www.biosim.es/
    • (2016) Internet
  • 117
    • 84898023506 scopus 로고    scopus 로고
    • Are biosimilars the next tool to guarantee cost-containment for pharmaceutical expenditures?
    • Farfan-Portet MI, Gerkens S, Lepage-Nefkens I, et al. Are biosimilars the next tool to guarantee cost-containment for pharmaceutical expenditures? Eur J Health Econ. 2014;15(3):223–228.
    • (2014) Eur J Health Econ , vol.15 , Issue.3 , pp. 223-228
    • Farfan-Portet, M.I.1    Gerkens, S.2    Lepage-Nefkens, I.3
  • 118
    • 85165709128 scopus 로고    scopus 로고
    • Jun, cited 2016 Jun 14, Available from
    • IMS Health. The Impact of Biosimilar Competition. [Internet]. 2016 Jun. [cited 2016 Jun 14]. Available from: http://www.medicinesforeurope.com/wp-content/uploads/2016/08/IMS-Impact-of-Biosimilar-Competition-2016.pdf
    • (2016) The Impact of Biosimilar Competition. [Internet
  • 119
    • 84954522648 scopus 로고    scopus 로고
    • Biosimilars: how can payers get long-term savings?
    • 1
    • Mestre-Ferrandiz J, Towse A, Berdud M. Biosimilars: how can payers get long-term savings? Pharmacoeconomics. 2016. 1. 34(6):609–616.
    • (2016) Pharmacoeconomics , vol.34 , Issue.6 , pp. 609-616
    • Mestre-Ferrandiz, J.1    Towse, A.2    Berdud, M.3
  • 121
    • 84884211461 scopus 로고    scopus 로고
    • Market entry of biosimilar low-molecular-weight heparins in Europe: opportunities and challenges
    • Simoens S, Huys I. Market entry of biosimilar low-molecular-weight heparins in Europe: opportunities and challenges. Semin Thromb Hemost. 2013;39:250–257.
    • (2013) Semin Thromb Hemost , vol.39 , pp. 250-257
    • Simoens, S.1    Huys, I.2
  • 122
    • 33846880007 scopus 로고    scopus 로고
    • Sustaining generic medicines markets in Europe
    • Simoens S, De Coster S. Sustaining generic medicines markets in Europe. J Generic Med. 2006;3(4):257–268.
    • (2006) J Generic Med , vol.3 , Issue.4 , pp. 257-268
    • Simoens, S.1    De Coster, S.2
  • 123
    • 85008261075 scopus 로고    scopus 로고
    • Analysis of European policy towards generic medicines
    • Dylst P, Vulto A, Simoens S. Analysis of European policy towards generic medicines. Gabi J. 2014;3(1):34–35.
    • (2014) Gabi J , vol.3 , Issue.1 , pp. 34-35
    • Dylst, P.1    Vulto, A.2    Simoens, S.3
  • 124
    • 84864375340 scopus 로고    scopus 로고
    • A review of generic medicine pricing in Europe
    • Simoens S. A review of generic medicine pricing in Europe. Gabi J. 2012;1(1):8–12.
    • (2012) Gabi J , vol.1 , Issue.1 , pp. 8-12
    • Simoens, S.1
  • 125
    • 85165624538 scopus 로고    scopus 로고
    • Trends hot topic. Report DMKC0061712
    • Feb, 23,. [cited 2016 Jun 14]. Available from
    • Hollis M. Trends hot topic. Report DMKC0061712. Datamonitor Healthc. [Internet]. 2011 Feb 23. [cited 2016 Jun 14]. Available from: www.datamonitorhealthcare.com
    • (2011) Datamonitor Healthc. [Internet
    • Hollis, M.1
  • 126
    • 85108450700 scopus 로고    scopus 로고
    • Potential societal value of biosimilars adoption: the example of UK
    • Milan, Italy: 7-11, Nov, cited 2016 Jun 14, Available from
    • Mendoza C, Ionescu D, Radière G, et al. Potential societal value of biosimilars adoption: the example of UK. ISPOR 18th Annual European Congress; Milan, Italy; 7-11 Nov, 2015. [cited 2016 Jun 14]. Available from: http://www.ispor.org/research_pdfs/51/pdffiles/PHP279.pdf
    • (2015) ISPOR 18th Annual European Congress
    • Mendoza, C.1    Ionescu, D.2    Radière, G.3
  • 127
    • 84929610400 scopus 로고    scopus 로고
    • Viewpoint: knowledge and viewpoints on biosimilar monoclonal antibodies among members of the European Crohn’s and colitis organization
    • 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.
    • (2014) J Crohns Colitis , vol.8 , Issue.11 , pp. 1548-1550
    • Danese, S.1    Fiorino, G.2    Michetti, P.3
  • 128
    • 85008248848 scopus 로고    scopus 로고
    • Biosimilars naming, label transparency and authority of choice–survey findings among European physicians
    • Dolinar RO, Reilly MS. Biosimilars naming, label transparency and authority of choice–survey findings among European physicians. Gabi J. 2014;3(2):58–62.
    • (2014) Gabi J , vol.3 , Issue.2 , pp. 58-62
    • Dolinar, R.O.1    Reilly, M.S.2
  • 129
    • 84938739042 scopus 로고    scopus 로고
    • Attitudes towards subsequent entry biologics/biosimilars: A survey of Canadian rheumatologists
    • Grabowski D, Henderson B, Lam D, et al. Attitudes towards subsequent entry biologics/biosimilars: A survey of Canadian rheumatologists. Clin Rheumatol. 2015;34(8):1427–1433.
    • (2015) Clin Rheumatol , vol.34 , Issue.8 , pp. 1427-1433
    • Grabowski, D.1    Henderson, B.2    Lam, D.3
  • 131
    • 84962773248 scopus 로고    scopus 로고
    • Physicians prefer greater detail in the biosimilar label (SmPC) Results of a survey across seven European countries
    • Hallersten A, Fürst W, Mezzasalma R. Physicians prefer greater detail in the biosimilar label (SmPC) Results of a survey across seven European countries. Regul Toxicol Pharm. 2016;77:275–281.
    • (2016) Regul Toxicol Pharm , vol.77 , pp. 275-281
    • Hallersten, A.1    Fürst, W.2    Mezzasalma, R.3
  • 132
    • 85008257140 scopus 로고    scopus 로고
    • Biosimilars: patient and physician acceptability is the fifth hurdle to market competition
    • Lyles A. Biosimilars: patient and physician acceptability is the fifth hurdle to market competition. Gabi J. 2015;4(1):6–7.
    • (2015) Gabi J , vol.4 , Issue.1 , pp. 6-7
    • Lyles, A.1
  • 133
    • 84964608856 scopus 로고    scopus 로고
    • Switching to biosimilar infliximab (CT-P13): evidence of clinical safety, effectiveness and impact on public health
    • Brown J, Kudrin A. Switching to biosimilar infliximab (CT-P13): evidence of clinical safety, effectiveness and impact on public health. Biologicals. 2016;44(4):1–10.
    • (2016) Biologicals , vol.44 , Issue.4 , pp. 1-10
    • Brown, J.1    Kudrin, A.2
  • 134
    • 85165693548 scopus 로고    scopus 로고
    • cited, 2016, Jun, 14, Available from
    • ClinicalTrials website. [Internet]. 2016. [cited 2016 Jun 14]. Available from: https://clinicaltrials.gov
    • (2016) ClinicalTrials website. [Internet
  • 135
    • 85165682592 scopus 로고    scopus 로고
    • Oct, 02, cited 2016 Jun 14, Available from
    • GaBi website. Another infliximab switch study started. [Internet]. 2015 Oct 02. [cited 2016 Jun 14]. Available from: http://gabionline.net/Biosimilars/News/Another-infliximab-switching-trial-started
    • (2015) Another infliximab switch study started. [Internet


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.