Key drivers for market penetration of biosimilars in Europe

References

• European Medicines Agency Website. Medicines [Internet]; [ cited 2016 Jan 18]. Available from: http://www.ema.europa.eu/ema/index.jsp?curl=pages/includes/medicines/medicines_landing_page.jsp&mid
   Google Scholar
• IMS Health. Assessing biosimilar uptake and competition in European markets [Internet]. [ updated 2014 Oct; cited 2016 Jan 18]. Available from: https://www.imshealth.com/files/web/IMSH%20Institute/Healthcare%20Briefs/Assessing_biosimilar_uptake_and_competition_in_European_markets.pdf
   Google Scholar
• GaBi Online. US$67 billion worth of biosimilar patents expiring before 2020 [Internet]. [ updated 2014 Jan 20; cited 2016 Jan 18]. Available from: http://www.gabionline.net/Biosimilars/General/US-67-billion-worth-of-biosimilar-patents-expiring-before-2020
   Google Scholar
• European Commission. What you need to know about Biosimilar Medicinal Products. Consensus Information Paper [Internet]. 2013 [ cited 2016 Jan 18]. Available from: http://ec.europa.eu/DocsRoom/documents/8242/attachments/1/translations/en/renditions/native
   Google Scholar
• European Commission. Project Group on Market Access and Uptake of Biosimilars. Terms of Reference [Internet]. [ updated 2011 Apr 2; published 2014 Nov 19; cited 2016 Jan 18]. Available from: http://ec.europa.eu/DocsRoom/documents/7616?locale=en
   Google Scholar
• European Commission. Communication from the commission. Executive summary of the pharmaceutical sector inquiry report [Internet]. [ updated 2009 Jul 8; cited 2016 Jan 18]. Available from: http://ec.europa.eu/competition/sectors/pharmaceuticals/inquiry/communication_en.pdf
   Google Scholar
• European Commission. Workshop on Access to and Uptake of Biosimilar Medicinal products. Summary [Internet]; [2015 Oct 6; cited 2016 Jan 18]. Available from: http://ec.europa.eu/DocsRoom/documents/14550/attachments/1/translations/en/renditions/native
   Google Scholar
• Farfan-Portet M-I, Gerkens S, Lepage-Nefkens I, et al. Are biosimilars the next tool to guarantee cost-containment for pharmaceutical expenditures? Eur J Health Econ. 2014;15:1–15.
   Web of Science ®Google Scholar
• Grabowski HG, Ridley DB, Schulman KA. Entry and Competition in Generic Biologicals. Manag Decis Econ. 2007;28(4–5):439–451.
   Google Scholar
• Chauhan D, Towse A, Mestre Ferrandiz J The market for biosimilars: evolution and policy options. Office of health economics (OHE) [Internet]. [ updated 2008 Oct; cited 2016 Jan 18]. Available from: https://www.ohe.org/publications/market-biosimilars-evolution-and-policy-options
   Google Scholar
• European Biopharmaceutical Enterprises. What pricing and reimbursement policies to use for off-patent biologicals? Results from the EBE 2014 biological medicines policy survey. Gabi Journal. 2015;4(1):17–24.
   Google Scholar
• Haustein R, De Millas C, Höer A, et al. Saving money in the European healthcare systems with biosimilars. Gabi Journal. 2012;1(3–4):120–126.
   Google Scholar
• Rovira J, Espín J, García L, et al. The impact of biosimilars’ entry in the EU market. Andalusian School of Public Health, Granada [Internet]. [ updated 2011 Jan; cited 2016 Jan 18]. Available from: http://ec.europa.eu/DocsRoom/documents/7651/attachments/1/translations/en/renditions/pdf
   Google Scholar
• Lepage-Nefkens I, Gerken S, Vinck I, et al. Barriers and opportunities for the uptake of biosimilar medicines in Belgium. Health Services Research (HSR). Brussels: Belgian Health Care Knowledge Centre (KCE); 2013. KCE Reports 199. D/2013/10.273/13.
   Google Scholar
• Grabowski H, Guha R, Salgado M. Biosimilar competition: lessons from Europe. Nat Rev Drug Discov. 2014 Feb;13(2):99–100.
   PubMed Web of Science ®Google Scholar
• 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 Jun;12(3):315–326.
   Google Scholar
• Mestre-Ferrandiz J, Towse A, Berdud M. Biosimilars: how can payers get long-term savings? Pharmacoeconomics. 2016 Jun;34(6):609–616.
   Web of Science ®Google Scholar
• Rovira J, Lindner L, Giménez E, et al. Biosimilars in the European market. Gabi Journal. 2013;2(1):30–35.
   Google Scholar
• Renwick MJ, Smolina K, Gladstone EJ, et al. Postmarket policy considerations for biosimilar oncology drugs. Lancet Oncol. 2016 Jan;17(1):e31–8.
   PubMed Web of Science ®Google Scholar
• Bocquet F, Paubel P, Fusier I, et al. Biosimilar versus patented erythropoietins: learning from 5 years of European and Japanese experience. Appl Health Econ Health Policy. 2015 Feb;13(1):47–59. DOI:10.1007/s40258-014-0125-6
   Web of Science ®Google Scholar
• IMS Health. The impact of biosimilar competition. Five observations by IMS health [Internet]. 2015 [ cited 2016 Jan 18]. Available from: http://ec.europa.eu/DocsRoom/documents/14548/attachments/1/translations/en/renditions/native
   Google Scholar
• Grabowsky H Biosimilar competition: lessons from Europe and prospects for the US. Seminar briefing 15. Office of Health Economics [Internet]. [ updated 2014 Oct; cited 2016 Jan 18]. Available from: https://www.ohe.org/news/biosimilar-competition-lessons-europe-and-prospects-us
   Google Scholar
• OECD Health Data. Health expenditure and financing: OECD Health Statistics (database) [Internet]. [ updated 2014 Jun 30; cited 2016 Jan 18]. doi: 10.1787/pharmexpcap-table-2014-1-en.
   Google Scholar
• OECD Data. Demography, Population [Internet]. 2012 [ cited 2016 Jan 18]. Available from: https://data.oecd.org/pop/population.htm
   Google Scholar
• Rémuzat C, Kapuśniak A, Caban A, et al. Supply-side and demand-side policies for biosimilars: an overview in 10 European Member States. 2016.
   Google Scholar
• EMA (EMEA). Guideline on similar biological medicinal products. CHMP/437/04 [Internet]. [ updated 2005 Oct 30; cited 2016 Jan 18]. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003517.pdf
   Google Scholar
• IGES. Value of generic medicines. Study Report for the European Generic Medicines Association [Internet]. [ updated 2015 Oct 5; cited 2016 Jan 18]. Available from: http://www.progenerika.de/wp-content/uploads/2015/11/IGES-Study-Report_Value-of-Generics_Oktober-2015.pdf
   Google Scholar
• National Institute for Health and Disability Insurance (INAMI). Reference reimbursement system [Internet]. [ updated 2015 Mar 25; cited 2016 Jan 18]. Available from: http://www.inami.fgov.be/fr/themes/cout-remboursement/par-mutualite/medicament-produits-sante/remboursement/specialites/Pages/systeme-remboursement-reference.aspx#.Vqfx-OgrLIU
   Google Scholar
• French Generic Medicines Association (GEMME). Pricing and reimbursement of generics [Internet]. [ cited 2016 Jan 18]. Available from: http://www.medicamentsgeneriques.info/son-cadre-reglementaire-et-sanitaire/prix-et-admission-au-remboursement/
   Google Scholar
• European Observatory on Health Systems and Policies. Health Systems in Transition (HiT) profile of Germany [Internet]. 2014 [ cited 2016 Jan 18]. Available from: http://www.hspm.org/countries/germany28082014/livinghit.aspx?Section=5.6%20Pharmaceutical%20care&Type=Section
   Google Scholar
• Anastasaki E, Bradshaw S, Proach J, et al. The Geek Healthcare reform after Troika: the potential impact on global pricing and access strategy. Poster, ISPOR congress, 17th Annual European Congress, Amsterdam, The Netherlands [Internet]. [ updated 2014 Nov; cited 2016 Jan 18]. Available from: http://www.ispor.org/research_pdfs/48/pdffiles/PHP152.pdf
   Google Scholar
• WHO Collaborating Centre for Pharmaceutical Pricing and Reimbursement Policies. Hungary Poster [Internt]. 2012 [ cited 2016 Jan 18]. Available from: http://whocc.goeg.at/Literaturliste/Dokumente/CountryInformationPosters/10e_HU_Poster_NemethGergely_2012.pdf
   Google Scholar
• Italian Ministry of Health. Decree ”Criteri di individuazione degli scaglioni per la negoziazione automatica dei generici e dei biosimilari” [Internet]. [ updated 2013 Apr 4; cited 2016 Jan 18]. Available from: http://www.gazzettaufficiale.it/eli/id/2013/06/06/13A04795/sg
   Google Scholar
• GaBi. Policies and legislation. Poland [Internet]. [ updated 2013 Nov 26; cited 2016 Jan 18]. Available from: http://www.gabionline.net/layout/set/print/Country-Focus/Poland/Policies-and-Legislation
   Google Scholar
• Aeseg website [Internet]. [ cited 2016 Jan 18]. Available from: http://www.aeseg.es/es/preguntas-frecuentes-medicamentos-genericos
   Google Scholar
• TLV website. Ceiling price [Internet]. [ Updated 2015 Oct 28; cited 2016 Jan 18]. Available from: http://www.tlv.se/lakemedel/takpriser/
   Google Scholar
• Toumi M, Rémuzat C. EU Pharmaceutical expenditure forecast [Internet]. [ updated 2012 Nov 26; cited 2016 Jan 18]. Available from: http://ec.europa.eu/health/healthcare/docs/creativ_ceutical_eu_pharmaceutical_expenditure_forecast.pdf
   Google Scholar
• GaBi. Policies and legislation. United Kingdom [Internet]. [ updated 2015 Apr 16; cited 2016 Jan 18]. Available from: http://www.gabionline.net/Country-Focus/United-Kingdom/Policies-and-Legislation
   Google Scholar
• Swartenbroekx N, Espín J, Gerkens S. Incentives for market penetration of biosimilars in Belgium and in five European countries. J Pharm Belg. 2014 Dec;4(4):36–46.
   Google Scholar
• Dylst P, Vulto A, Simoens S. Barriers to the uptake of biosimilars and possible solutions: A Belgian case study. PharmacoEconomics. 2014 Jul 1;32(7):681–691.
   PubMed Web of Science ®Google Scholar
• NHS Business Services Authority. Prescribing budgets [Internet]. 2012; [ cited 2016 Jan 18]. Available from: http://www.nhsbsa.nhs.uk/PrescriptionServices/3996.aspx
   Google Scholar
• HSCIC. Quality and Outcomes Framework – Prevalence, Achievements and Exceptions Report, England 2014-15 [Internet]. [ updated 2015 Oct 29; cited 2016 Jan 18]. Available from: http://www.hscic.gov.uk/qof
   Google Scholar
• INAMI. Prescrire en DCI: règles pour le pharmacien qui exécute la prescription [Internet]. [ updated 2014 Nov 25; cited 2016 Jan 18]. 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#.VvOqMuLhDIV
   Google Scholar
• 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 Aug 1;29(4):275–284.
   PubMed Web of Science ®Google Scholar
• demosEUROPA. Biologics in the Polish health system [Internet]. 2015; [ cited 2016 Jan 18]. Available from: http://www.infarma.pl/assets/files/innowacje/Biologics_in_the_Polish_health_system.pdf
   Google Scholar
• Rencz F, Kemény L, Gajdácsi JZ, et al. Use of biologics for psoriasis in Central and Eastern European countries. J Eur Acad Dermatol Venereol. 2015 Nov 1;29(11):2222–2230.
   Web of Science ®Google Scholar
• Rencz F, Péntek M, Bortlik M, et al. Biological therapy in inflammatory bowel diseases: access in Central and Eastern Europe. World J Gastroentero. 2015 Feb 14;21(6):1728.
   PubMed Web of Science ®Google Scholar
• Paul-Ehrlich-Institut. Position des Paul-Ehrlich-Instituts zum Einsatz von Biosimilars [Internet]. [ updated 2015 Dec 8; cited 2016 Jan 18]. Available from: http://www.pei.de/DE/arzneimittel/immunglobuline-monoklonale-antikoerper/monoklonale-antikoerper/zusatz/position-pei-interchangebility-biosimilars-inhalt.html
   Google Scholar
• Hedlund F Landsting börjar switcha till biosimilar [Internet]. [ updated 2015 Aug 25; cited 2016 Jan 18]. Available from: http://svenskfarmaci.se/lakemedel/landsting-borjarswitcha-till-biosimilar/
   Google Scholar
• AIFA. Position Paper sui Farmaci Biosimilari [Internet]. [ updated 2013 May 13; cited 2016 Jun 14]. Available from: http://www.agenziafarmaco.gov.it/sites/default/files/AIFA_POSITION_PAPER_FARMACI_BIOSIMILARI.pdf
   Google Scholar
• Drozd 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.
   Google Scholar
• Läkemedelsverkets. Kriterier för utbytbarhet [Internet]. [ updated 2014 Oct 29; cited 2016 Jan 18]. Available from: https://lakemedelsverket.se/malgrupp/Halso—sjukvard/Forskrivning/Utbytbara-lakemedel-/Kriterier-for-utbytbarhet/
   Google Scholar
• Läkemedelsverkets. Substitutable Medicinal Products [Internet]. [ updated 2015 Sep 30; cited 2016 Jan 18]. Available from: https://lakemedelsverket.se/upload/halso-och-sjukvard/forskrivning/utbytbarhet/Utbytbara%20l%C3%A4kemedel%20(hela%20listan)%202015-09-30.pdf
   Google Scholar
• Ministry of Health. Letter MZ-PLA-460-15149-316/BRB/14 [Internet]. [ updated 2014 Jun 10; cited 2016 Jan 18]. Available from: http://www.nfz-wroclaw.pl/download.ashx?id=/45418/pisma%20MZ%20ws%20lek%F3w%20biopodobnych.pdf
   Google Scholar
• Legifrance. LOI n° 2013-1203 du 23 décembre 2013 de financement de la sécurité sociale pour 2014 [Internet]. [ updated 2013 Dec 23; cited 2016 Jan 18]. Available from: https://www.legifrance.gouv.fr/affichTexte.do?cidTexte=JORFTEXT000028372809&categorieLien=id
   Google Scholar
• GaBi. Policies and legislatio. Italy [Internet]. [ updated 2013 Aug 30; cited 2016 Jan 18]. Available from: http://www.gabionline.net/Country-Focus/Italy/Policies-and-Legislation
   Google Scholar
• G-BA website. Reference prices and how they are set [Internet]. [ cited 2016 Jan 18]. Available from: http://www.english.g-ba.de/special-topics/pharmaceuticals/reference/
   Google Scholar
• The Pharma Letter. UK lags behind some European countries in biosimilars uptake, new study finds [Internet]. [ updated 2013 Sep; cited 2016 Jan 18]. Available from: http://www.thepharmaletter.com/article/uk-lags-behind-some-european-countries-in-biosimilars-uptake-new-study-finds
   Google Scholar
• NHS. What is a biosimilar medicine. September 2015 [Internet]. [ updated 2015 Sep 24; cited 2016 Jan 18]. Available from: https://www.england.nhs.uk/wp-content/uploads/2015/09/biosimilar-guide.pdf
   Google Scholar
• NICE. Technology appraisal support [HTTA329]. Introducing biosimilar versions of infliximab: Inflectra and Remsima [Internet]. [ updated 2015 Jul 31; cited 2016 Jan 18]. Available from: http://www.biosimilars-nederland.nl/wp-content/uploads/2015/08/NICE-Adoption-Resource-Biosimilar-Infliximab-2015_07_31.pdf
   Google Scholar
• Daubenfeld T, Dassow J, Keßler M, et al. Understanding the market dynamics of biosimilars. J Business Chem. 2016 Feb;13(1):33–46.
   Google Scholar
• Khraishi M, Stead D, Lukas M, et al. Biosimilars: A Multidisciplinary Perspective. Clin Ther. 2016 May;38(5):1238–1249.
   Web of Science ®Google Scholar
• European.eu. Member countries of the EU (year of entry) [Internet]; [ cited 2016 Jan 18]. Available from: https://europa.eu/european-union/about-eu/countries_en
   Google Scholar
• OECD Data. Gross domestic product [Internet]. 2014; [ cited 2016 Jan 18]. Available from: https://data.oecd.org/gdp/gross-domestic-product-gdp.htm
   Google Scholar
• OECD. Health at a Glance 2015: OECD Indicators. Paris: OECD Publishing; 2015. DOI:10.1787/health_glance-2015-en
   Google Scholar