References
- Carone G, Schwierz C, Xavier A. Cost-containment policies in public pharmaceutical spending in the EU. [Internet]. 2012 Sep 14. [ cited 2016 Jun 14]. Available from: http://ec.europa.eu/economy_finance/publications/economic_paper/2012/pdf/ecp_461_en.pdf
- 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
- European Commission. Ageing, Policy. [Internet]. [ cited 2016 Jun 14]. Available from: http://ec.europa.eu/health/ageing/policy/index_en.htm
- 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
- WHO. Access to new medicines in Europe: technical review of policy initiatives and opportunities for collaboration and research. [Internet]. 2015 Mar. [ cited 2016 Jun 14]. Available from: http://www.euro.who.int/__data/assets/pdf_file/0008/306179/Access-new-medicines-TR-PIO-collaboration-research.pdf?ua=1
- IMS Health. Delivering on the Potential of Biosimilar Medicines. The Role of Functioning Competitive Markets. [Internet]. 2016 Mar. [ cited: April 2016]. Available from: https://www.imshealth.com/files/web/IMSH%20Institute/Healthcare%20Briefs/Documents/IMS_Institute_Biosimilar_Brief_March_2016.pdf
- European Commission. Investing In Health: Commission Staff Working Document, Social Investment Package. [Internet]. 2013 Feb 20. [ cited 2016 Jun 14]. Available from: http://ec.europa.eu/health/strategy/docs/swd_investing_in_health.pdf
- European Commission. Joint report on health systems. Occasional Papers 74.[Internet]. 2010 Dec. [ cited 2016 Jun 14]. Available from: http://europa.eu/epc/pdf/joint_healthcare_report_en.pdf
- European Commission. Workshop on Access to and Uptake of Biosimilar Medicinal products. Summary. [Internet]. 2015 Oct 06. [ cited 2016 Jun 14]. Available from: http://ec.europa.eu/DocsRoom/documents/14550/attachments/1/translations/en/renditions/native
- European Commission. Communication from the commission. Executive summary of the pharmaceutical sector inquiry report. [Internet]. 2009 Jul 08. [ cited 2016 Jun 14]. Available from: http://ec.europa.eu/competition/sectors/pharmaceuticals/inquiry/communication_en.pdf
- 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
- 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)
- 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
- The WHO Collaborating Centre for Pricing and Reimbursement Policies. Glossary. [Internet]. [ cited 2016 Jun 14]. Available from: http://whocc.goeg.at/Glossary/PreferredTerms/
- 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
- 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
- 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.
- 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
- 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
- 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
- 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.
- 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
- Lepage-Nefkens I, Gerkens 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/2013/10273/13. [Internet]. [ cited 2016 Jun 14]. Available from: https://kce.fgov.be/sites/default/files/page_documents/KCE_199_2012-13-HSR_Biosimilars_report_0.pdf
- 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
- 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/
- Creativ-Ceutical internal proprietary database.
- Toumi M, Rémuzat C, Vataire A-L, et al. External reference pricing of medicinal products: simulation-based considerations for cross-country coordination. [Internet]. 2014 Dec. [ cited 2016 Jun 14]. Available from: http://ec europa eu/health/healthcare/docs/erp reimbursement_medicinal_product s_en pdf
- 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
- 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
- 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
- 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
- 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
- SMC. Guidance to manufacturers on medicines outwith SMC remit. [Internet]. 2015 May. [ cited 2015 Nov]. Available from: https://www.scottishmedicines.org.uk/
- SMC website. Biosimilar Medicines. [Internet]. 2015 May. [ cited 2016 Jun 14]. Available from: http://www.scottishmedicines.org.uk/About_SMC/Policy_statements/Biosimilar_Medicines
- 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
- Renwick MJ, Smolina K, Gladstone EJ, et al. Postmarket policy considerations for biosimilar oncology drugs. Lancet Oncol. 2016;17(1):e31–e8.
- 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
- 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
- French Healthcare Products Pricing Committee 2014/2015 annual report [Internet]. 2015 Sep. [ cited 2016 Jun 14]. Available from: http://social-sante.gouv.fr/IMG/pdf/rapport_annuel_2014_version_anglaise.pdf
- Schofield I, Greenfield P. Market access hot topic. Report DMKC0106980. Datamonitor Healthcare. [Internet]. Nov 11 2013. [cited 2016 Jun 14]. Available from: www.datamonitorhealthcare.com
- 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
- 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
- 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/
- 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.
- Martens M, Carbonnelle N, Sagal I, et al. White Paper Public procurement of medicinal products Common legislation but diverging implementation approaches throughout the EU. [Internet]. 2014. [ cited 2016 Jun 14]. Available from: http://www.twobirds.com/~/media/pdfs/white-papers/public-procurement-of-medicinal-products.pdf
- Leopold C, Habl C, Vogler S. Tendering of pharmaceuticals in EU member states and EEA countries. Results from the country survey ÖBIG Forschungsund Planungs GesmbH, Vienna. [Internet]. 2008 Jun. [ cited 2016 Jun 14]. Available from: http://whocc.goeg.at/Literaturliste/Dokumente/BooksReports/Final_Report_Tendering_June_08.pdf
- 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
- 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.
- 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
- Horvath B, Czech R. Reimbursement of biosimilar products in Hungary 2009-2015. [Internet]. 2015. [ cited 2015 Nov]. Available from: https://ec.europa.eu/commission/index_en
- Polish Public Procurement Law. Dz. U. 2013 poz. 907. [Internet]. [ cited 2016 Jun 14]. Available from: http://isap.sejm.gov.pl/DetailsServlet?id=WDU20040190177
- 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
- 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
- Pacte d’avenir pour le patient avec l’industrie pharmaceutique. [Internet]. 2015. [ cited 2016 Jun 14]. Available from: http://www.deblock.belgium.be/sites/default/files/articles/20150727%20Pacte%20d’avenir.pdf
- 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.
- EGA. Survey on good practices and obstacles of the market uptake of biosimilars in member states and EEA countries. 2012. [ cited 2015 Nov]. Available from: http://www.egagenerics.com/images/Website/MS_Survey_on_Biosimilars_presentation.pdf
- 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.
- 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.
- 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.
- Regione Campania. Decreto n. 27 del 15.03.2013. Misure di incentivazione della prescrizione di farmaci a brevetto scaduto e dei farmaci biosimilari. [Internet]. 2013 Mar 17. [ cited 2016 Jun 14]. Available from: http://www.arsan.campania.it/documents/10157/59773/DCA_27_13.pdf
- 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
- 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
- NHS Business Services Authority. Prescribing budgets. [Internet]. 2015. [ cited 2016 Jun 14]. Available from: http://www.nhsbsa.nhs.uk/PrescriptionServices/3996.aspx
- HSCIC. Quality and Outcomes Framework. [Internet] 2015. [ cited 2016 Jun 14]. Available from: http://www.hscic.gov.uk/qof
- 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
- Regione Campania. Decreto Commissariale n. 66 del 14.07.2016. Misure di incentivazione dei farmaci a brevetto scaduto e dei biosimilari. [Internet]. 2016 Jul 14. [ cited 2016 Sep 20]. Available from: http://www.medinco.it/medinco/wp-content/uploads/2016/07/DCA-n.-66-del-14.07.2016.pdf
- AIFA. Nota Informativa Importante su Granulokine (Filgrastim) e Neulasta (Pegfilgrastim). [Internet]. 2013 Aug 26. [ cited 2016 Jun 14]. Available from: http://www.agenziafarmaco.gov.it/it/content/nota-informativa-importante-su-granulokine-filgrastim-e-neulasta-pegfilgrastim-26082013
- 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
- Hedlund F Landsting börjar switcha till biosimilar. [Internet]. 2015 Aug 25. [ cited 2016 Jun14]. Available from: http://svenskfarmaci.se/lakemedel/landsting-borjarswitcha-till-biosimilar/
- 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.
- 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
- 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.
- 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#
- 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.
- AIFA. Piano terapeutico per la prescrizione di eritropoietine (ex nota 12). [Internet]. [ cited 2016 Jun 14]. Available from: http://www.agenziafarmaco.gov.it/it/content/piano-terapeutico-la-prescrizione-di-eritropoietine-ex-nota-12
- 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
- NICE. Human growth hormone (somatropin) for the treatment of growth failure in children. Technology appraisal guidance [TA188]. [Internet]. 2010 May 26. [ cited 2016 Jun 14]. Available from: https://www.nice.org.uk/guidance/ta188/chapter/the-technologies
- NICE. Infliximab, adalimumab and golimumab for treating moderately to severely active ulcerative colitis after the failure of conventional therapy Technology appraisal guidance [TA 329]. [Internet]. 2015 Feb 25. [ cited 2016 Jun 14]. Available from: https://www.nice.org.uk/guidance/ta329/resources/infliximab-adalimumab-and-golimumab-for-treating-moderately-to-severely-active-ulcerative-colitis-after-the-failure-of-conventional-therapy-82602495307717
- 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
- NICE. Adalimumab, etanercept, inflfliximab, certolizumab pegol, golimumab, tocilizumab and abatacept for rheumatoid arthritis not previously treated with DMARDs or after conventional DMARDs only have failed. Technology appraisal guidance [TA375]. [Internet]. 2016 Jan 26. [ cited 2016 Jun 14]. Available from: https://www.nice.org.uk/guidance/ta375/resources/adalimumab-etanercept-infliximab-certolizumab-pegol-golimumab-tocilizumab-and-abatacept-for-rheumatoid-arthritis-not-previously-treated-with-dmards-or-after-conventional-dmards-only-have-failed-82602790920133
- 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
- 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
- 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
- Hernández GC, Puig L. The use of biosimilar drugs in psoriasis: a position paper. Actas Dermosifiliogr. 2015;4(106):249–251.
- 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.
- BSG. BSG Guidance on the Use of Biosimilar Infliximab CT-P13 in Inflammatory Bowel Disease. [Internet]. 2016 Feb. [ cited 2016 Jun 14]. Available from: http://www.bsg.org.uk/images/stories/docs/clinical/guidance/bsg_infliximab_guidance_16.pdf
- 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
- 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
- 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)
- 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)
- 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.
- Legifrance. LOI n° 2013-1203 du 23 décembre 2013 de financement de la sécurité sociale pour 2014.[Internet]. [ cited 2016 Jun 14]. Available from: http://www.legifrance.gouv.fr/affichTexte.do?cidTexte=JORFTEXT000028372809&categorieLien=id
- Del Estado BO. LEY 29/2006 de 26 de julio, de garantías y uso racional de los medicamentos y productos sanitarios. BOE nm. 2015;178. [Internet]. [ cited 2016 Jun 14]. Available from: https://www.boe.es/buscar/pdf/2006/BOE-A-2006-13554-consolidado.pdf
- Orden SCO/2874/2007, de 28 de septiembre, por la que se establecen los medicamentos que constituyen excepción a la posible sustitución por el farmacéutico con arreglo al artículo 86.4 de la Ley 29/2006, de 26 de julio, de garantías y uso racional de los medicamentos y productos sanitarios. BOE nm. 2014;239. [Internet], [ Cited 2016 Jun 14]. Available from: https://www.boe.es/buscar/pdf/2007/BOE-A-2007-17420-consolidado.pdf
- 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
- 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.
- Läkemedelsverkets. Kriterier för utbytbarhet. [Internet]. 2014. [ cited 2016 Jun 14]. Available from: https://lakemedelsverket.se/malgrupp/Halso—sjukvard/Forskrivning/Utbytbara-lakemedel-/Kriterier-for-utbytbarhet/
- 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
- 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
- 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
- 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
- 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
- GE website. Biosimilars. [Internet]. Available from: http://www.generikusegyesulet.hu/biosimilar-gyogyszerek/ ( cited 2016 Jun 14)
- 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
- Szymczyk M, Kieszkowska-Knapik P. Leczenie biologiczne – ważne informacje; Informator dla pacjenta. Instytut Praw Pacjenta i Edukacji Zdrowotnej. [Internet]. 2015. [ cited 2016 Jun 14]. Available from: http://www.infarma.pl/assets/files/innowacje/Leczenie_biologiczne_broszura.pdf
- 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
- FeBelGen website. Qu’est ce qu’un médicament biosimilaire? [Internet]. [ cited 2016 Jun 14]. Available from: http://www.febelgen.be/themes/biosimilaire.html
- GEMME. Médicaments biosimilaires: favoriser leur développement en France grâce à l’adhésion de toutes les parties prenantes. [Internet]. 2014 Oct 03. [ cited 2016 Jun 14]. Available from: http://www.medicamentsgeneriques.info/medicaments-biosimilaires-favoriser-leur-developpement-en-france-grace-a-ladhesion-de-toutes-les-parties-prenantes/
- ProGenerika website. Biosimilars. [Internet]. 2015. [ cited 2016 Jun 14]. Available from: http://www.progenerika.de/biosimilars/
- AssoGenerici website. Biosimilari. [Internet]. 2015. [ cited 2016 Jun 14]. Available from: http://www.assogenerici.org/2011/biosimilari.asp?s=2&p=1&modulo=biosimilari
- BGMA website. Biosimilars. [Internet]. 2015. [ cited 2015 Nov]. Available form: http://www.britishgenerics.co.uk/bgma-key-issues/biosimilars
- AESEG website. Acceso sostenible a medicamentos genéricos y biosimilares, prioridad para la Sanidad en España. [Internet]. 2015 Nov 17. [ cited 2016 Jun 14]. Available from http://www.aeseg.es/es/notas-de-prensa-2015/2291-acceso-sostenible-a-medicamentos-genericos-y-biosimilares-prioridad-para-la-sanidad-en-espana
- FGL website. Biosimilarer. [Internet]. 2015. [ cited 2015 Nov]. Available from: http://www.generikaforeningen.se/
- ProBiosimilars website. [Internet]. 2016. [ cited 2016 Jun 14]. Available from: http://probiosimilars.de/
- BBA website. [Internet]. 2016. [ cited 2016 Jun 14]. Available from: http://britishbiosimilars.co.uk/hot-topics
- BioSim website. [Internet]. 2016. [ cited 2016 Jun 14]. Available from: http://www.biosim.es/
- 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.
- 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
- Mestre-Ferrandiz J, Towse A, Berdud M. Biosimilars: how can payers get long-term savings? Pharmacoeconomics. 2016. 1. 34(6):609–616.
- Kanavos P, Vandoros S, Irwin R, et al. Differences in costs of and access to pharmaceutical products in the EU. [Internet]. 2011. [ cited 2016 Jun 14]. Available from: http://www.europarl.europa.eu/RegData/etudes/etudes/join/2011/451481/IPOL-ENVI_ET(2011)451481_EN.pdf
- Simoens S, Huys I. Market entry of biosimilar low-molecular-weight heparins in Europe: opportunities and challenges. Semin Thromb Hemost. 2013;39:250–257.
- Simoens S, De Coster S. Sustaining generic medicines markets in Europe. J Generic Med. 2006;3(4):257–268.
- Dylst P, Vulto A, Simoens S. Analysis of European policy towards generic medicines. Gabi J. 2014;3(1):34–35.
- Simoens S. A review of generic medicine pricing in Europe. Gabi J. 2012;1(1):8–12.
- Hollis M. Trends hot topic. Report DMKC0061712. Datamonitor Healthc. [Internet]. 2011 Feb 23. [cited 2016 Jun 14]. Available from: www.datamonitorhealthcare.com
- 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
- 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.
- Dolinar RO, Reilly MS. Biosimilars naming, label transparency and authority of choice–survey findings among European physicians. Gabi J. 2014;3(2):58–62.
- 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.
- Malik A. Biosimilars advisory service: US and EU payer perspectives on biosimilars. [Internet]. BioTrends Research Group; 2015. [cited 2016 Jun 14]. Available from: www.decisionresources.com
- 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.
- Lyles A. Biosimilars: patient and physician acceptability is the fifth hurdle to market competition. Gabi J. 2015;4(1):6–7.
- 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.
- ClinicalTrials website. [Internet]. 2016. [ cited 2016 Jun 14]. Available from: https://clinicaltrials.gov
- 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