Biosimilar medicines and cost-effectiveness

References

• NaglePCLugoTFNicitaCADefining and characterizing the late-stage biopharmaceutical pipelineAm J Manag Care20039Suppl 6S124S13514577717
   PubMed Web of Science ®Google Scholar
• YoungFEBiotechnology: the view from the FDAHealth Matrix198643101510279339
   PubMedGoogle Scholar
• ZunigaLCalvoBBiosimilars–the way forwardHosp Pharm Europe2010503334
   Google Scholar
• CohenMMorrowTPennaPManaging the expanded use of biologics across therapeutic areas: an example from b-cell targeted therapiesAm J Manag Care200612Suppl 2S24S3716551202
   PubMed Web of Science ®Google Scholar
• SimonFMarket access for biopharmaceuticals: new challengesHealth Aff (Millwood)20062551363137016966734
   PubMed Web of Science ®Google Scholar
• European Medicines AgencyGuideline on Similar Biological Medicinal Products2006 Available from: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003517.pdf. Accessed December 6, 2010
   Google Scholar
• United States CongressPatient Protection and Affordable Care Act2010 Available from: http://www.opencongress.org. Accessed December 6, 2010
   Google Scholar
• European Medicines AgencyGuideline on Similar Biological Medicinal Products Containing Monoclonal Antibodies2010 Available from http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2010/11/WC500099361.pdf. Accessed December 6, 2010
   Google Scholar
• European Medicines AgencyConcept Paper on Similar Biological Product Containing Recombinant Interferon BetaEuropean Medicines Agency2010 Available from: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2010/04/WC500089210.pdf. Accessed December 6, 2010
   Google Scholar
• European Generic Medicines AssociationVision 2015. The EGA’s Thoughts on How to Improve the Legal and Regulatory Framework for Generic and Biosimilar Medicines2010 Available from: http://www.egagenerics.com/doc/EGA_Vision_2015.pdf. Accessed December 6, 2010
   Google Scholar
• DrummondMSculpherMJTorranceGWO’BrienBJStoddartGLMethods for the Economic Evaluation of Health Care Programmes3rd edOxford, UKOxford University Press2005
   Google Scholar
• PerlethMJakubowskiEBusseRWhat is ‘best practice’ in health care? State of the art and perspectives in improving the effectiveness and efficiency of the European health care systemsHealth Policy200156323525011399348
   PubMed Web of Science ®Google Scholar
• MellstedtHNiederwieserDLudwigHThe challenge of biosimilarsAnn Oncol200819341141917872902
   PubMed Web of Science ®Google Scholar
• RogerSDGoldsmithDBiosimilars: it’s not as simple as cost aloneJ Clin Pharm Ther200833545946418834359
   PubMed Web of Science ®Google Scholar
• StewartAAubreyPBelseyJAddressing the health technology assessment of biosimilar pharmaceuticalsCurr Med Res Opin20102692119212620649394
   PubMed Web of Science ®Google Scholar
• European Medicines AgencyAnnex Guideline on Similar Biological Medicinal Products Containing Biotechnology-Derived Proteins as Active Substance: Non-Clinical and Clinical Issues. Guidance on Similar Medicinal Products Containing Somatropin2006 Available from: http://www.ema.europa.eu/pdfs/human/biosimilar/9452805en.pdf. Accessed December 7, 2010
   Google Scholar
• De MoraFTorresRBiotechnology-derived medicines: what are they? A pharmacological and a historical perspectiveJ Generic Med201072145157
   Google Scholar
• HughesDABiosimilars: evidential standards for health technology assessmentClin Pharmacol Ther201087325726120160743
   PubMed Web of Science ®Google Scholar
• HjelmgrenJBerggrenFAnderssonFHealth economic guidelines–similarities, differences and some implicationsValue Health20014322525011705185
   PubMedGoogle Scholar
• Scottish Medicines ConsortiumEpoetin Zeta Scottish Medicines Consortium; 2010. Available from: http://www.scottishmedicines.org.uk/smc/6094.html. Accessed December 7, 2010
   Google Scholar
• de JoncheereKRietveldAHHuttinCExperiences with genericsInt J Risk Safety Med200215101119
   Google Scholar
• KingDRKanavosPEncouraging the use of generic medicines: implications for transition economiesCroat Med J200243446246912187525
   PubMed Web of Science ®Google Scholar
• MellstedtHThe future of biosimilarsHosp Pharm Europe2010493334
   Google Scholar
• GrabowskiHCockburnILongGThe market for follow-on biologics: how will it evolve?Health Aff (Millwood)20062551291130116966725
   PubMed Web of Science ®Google Scholar
• LongMTroutJAkpinarPBiosimilars: HGH to TNFS, how will payers respondPriceSpective20091026
   Google Scholar
• European Generic Medicines AssociationEGA Handbook on Biosimilar Medicines2010 Available from: http://www.egagenerics.com/bio-handbook.htm. Accessed December 7, 2010
   Google Scholar
• OldhamTStrategies for entering the biosimilar marketOldhamTBiosimilars–Evolution or Revolution?London, UKBiopharm Knowledge Publishing2006
   Google Scholar
• KanavosPDo generics offer significant savings to the UK National Health Service?Curr Med Res Opin200723110511617257472
   PubMed Web of Science ®Google Scholar
• KanavosPTaylorDPharmacy discounts on generic medicines in France: is there room for further efficiency savings?Curr Med Res Opin200723102467247617764613
   PubMed Web of Science ®Google Scholar
• SienaSPiccartMJHolmesFAGlaspyJHackettJRenwickJJA combined analysis of two pivotal randomized trials of a single dose of pegfilgrastim per chemotherapy cycle and daily Filgrastim in patients with stage II–IV breast cancerOncol Rep200310371572412684649
   PubMed Web of Science ®Google Scholar
• Scottish Medicines ConsortiumRatiograstim2009 Available from: http://www.scottishmedicines.org.uk/files/filgrastim_Ratiograstim_FINAL_Oct_2009_Revised_031109.doc_for_website.pdf. Accessed December 8, 2010
   Google Scholar
• National Institute for Health and Clinical ExcellenceHuman Growth Hormone (Somatropin) for the Treatment of Growth Failure in Children (Review of NICE Technology Appraisal Guidance 42)2010 Available from: http://guidance.nice.org.uk/TA188. Accessed December 8, 2010
   Google Scholar
• CookJPVernonJAManningRPharmaceutical risk-sharing agreementsPharmacoeconomics200826755155618563946
   PubMed Web of Science ®Google Scholar
• ZaricGSXieBThe impact of two pharmaceutical risk-sharing agreements on pricing, promotion, and net health benefitsValue Health200912583884519490563
   PubMed Web of Science ®Google Scholar
• GeorgeBHarrisAMitchellACost-effectiveness analysis and the consistency of decision making: evidence from pharmaceutical reimbursement in Australia (1991 to 1996)Pharmacoeconomics200119111103110911735677
   PubMed Web of Science ®Google Scholar
• LaupacisAFeenyDDetskyASTugwellPXHow attractive does a new technology have to be to warrant adoption and utilization? Tentative guidelines for using clinical and economic evaluationsCMAJ199214644734811306034
   PubMed Web of Science ®Google Scholar
• RafteryJReview of NICE’s recommendations, 1999–2005BMJ200633275521266126816735341
   PubMed Web of Science ®Google Scholar
• Health Care Insurance BoardRichtlijnen voor farmaco-economisch onderzoek (Guidelines for Pharmaco-Economic Research)Amstelveen, The NetherlandsHealth Care Insurance Board1999
   Google Scholar
• PHARMACPrescription for Pharmacoeconomic Analysis: Methods for Cost-Utility AnalysisAuckland, NZPHARMAC2007
   Google Scholar
• GrosseSDAssessing cost-effectiveness in healthcare: history of the $50,000 per QALY thresholdExpert Rev Pharmacoecon Outcomes Res20088216517820528406
   PubMedGoogle Scholar
• IMS HealthMidas DatabaseLondon, UKIMS Health2008
   Google Scholar