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Follow-OnBiologics:Economic,InnovationandPolicyReflectionsTheFuquaSchoolofBusinessDukeUniversityNovember6-7,2008av72电影“CommercialOpportunitiesandChallengesforFollow-onBiologics”PresentationOverview•GenericBiologics–CommercialOpportunities&Savings–Science&TechnologyChallenges–Regulatory&IntellectualPropertyIssues•SummaryCommercialOpportunities&SavingsBenefitsofGenericCompetition•SignificantCostSavingOpportunities–Savingsforconsumersandtaxpayers•GenericCompetitionWillFuelInnovation–BrandcompanieswillhavetheincentiveneededtovigorouslypursuenewbiologicsIncreasingSignificanceofBiologicProducts•USBiologicRevenues–1997:$17.4Billion–2007:$65.2Billion*•400Biologics&VaccinesCurrentlyinClinicalTrialsTargeting200Diseases**•Between2003and2006,biologicsrepresented24%ofallnewchemicalentitiesapprovedbytheUS***•SalesofbiotechproductsintheUSshowedanannualgrowthrateof20%between2001and2006comparedwith6%to8%inthepharmaceuticalmarket****Ernst&Young**BiotechnologyIndustryOrganization***JournalofAmericanMedicalAssociation,October22,2008HighCostofBrandBiologicsAnnualCostperPatient•Enbrel(Arthritis)$20,000*•Cerezyme(GaucherDisease)$200,000**•Remicade(Arthritis)$35,000-$66,000***GenericCompetitionWillReduceTheseCosts*BaltimoreSunJanuary28,2007**BloombergJanuary11,2007***PhiladelphiaInquirerSeptember19,2006SignificantCostSavingsOpportunityGenericBiologicsRepresentSignificantCostSavingsOpportunitiesandStimulateInnovationEpogen•MarketBeforeGenericLaunch:$2.5Billion*•Brand/YearToday:$9,000**•GenericSavings/Yearassuming50%savings:$4,500Enbrel•MarketBeforeGenericLaunch:$2.7Billion*•Brand/YearToday:$20,000***•GenericSavings/Yearassuming50%savings:$10,000*ABNAMROFebruary2008**NationalJournalFebruary10,2007***BaltimoreSunJanuary28,2007GenericCompetitionPriceDropsasNumberofManufacturersIncreasesMarketSizeforSelectBiologicProductsProduct2006Sales($Millions)PatentExpirationAranesp(Darbapoteinalfa)$2,7902016Enbrel(Etanercept)$2,7362012Epogen(Epoteinalfa)$2,5112004Remicade(Infliximab)$2,3552013Rituxan(Rituximab)$2,0712013Eprex(OrthoBiotech)$2,0642004Avastin(Bevacizumab)$1,7462019Rebetron(Ribavirin&Interferonalfa-2B)$1,3612001Lantus(Insulinglargine)$1,2602015Source:ABNAMROFebruary2008MarketSizeforSelectBiologicProductsProduct2006Sales($Millions)PatentExpirationHumira(Adalimumab)$1,1762013Avonex(Interferonbeta-1a)$1,0222003Cerezyme(Imiglucerase)$1,0072010Neupogen(Filgrastim)$8302013Humalog(Insulinlispro)$8112013Ceredase(alglucerase)$5372001Rebif(Interferonbeta-1a)$4932005Neulasta(Pegfilgrastim)$4932015Source:ABNAMROFebruary2008Perspective:HistoricalGrowthinSubstitution010203040506070198419851986198719881989199019911992199319941995199619971998199920002001200220032004200520062007Source:IMSHealth,BancofAmericaSecuritiesLLCestimatesGenericBiologicsOpportunity•GenericPharmaceuticals-AVitalPartinHealthCareSystem–Approximately67%ofthePrescriptionsDispensedintheUSAreGenerics*•Biologics–WorldwideMarketEstimatedaround$75Billion*–PerPatientCostforBiologicProductsCanExceed$100,000PerYear•GenericBiologics–USConsumersCouldSave$43BillionBetween2011and2020**–EstimatedValueofBiologicsthathavealreadylostPatentProtection:$10Billion***–EstimatedValueofBiologicstolosePatentProtectionintheNextTenYears:$20Billion****IMSHealth**CitizensAgainstGovernmentWaste(CAGW)Release,May2,2007***ABNAMROFebruary2008Science&TechnologyChallengesScientificChallengesforGenericBiologics•Characterization•SafetyAssessment•TherapeuticEquivalence•ManufacturingControlsGenericBiologics•Genericbiologics,sometimescalledfollow-onbiologics(FOBs),areproteinproductsthatarepharmaceuticallyandtherapeuticallyequivalent•Genericbiologicsdonotutilizethereferenceproduct’sproprietaryprocess,specificationsorclinicaldata•Forestablishedproducts,therapeuticequivalencecanbedemonstratedusing–Invitrostudiesand/or–Pharmacokineticsand/or–Surrogatemarkersand/or–ClinicaloutcomesdependingonthecharacteristicsoftheproteinInterferon2804atomsMonoclonalAntibody21112atomsrDNATechnologyDrugs:Filgrastim(G-CSF)2659atomsBiologicsSizeDoesMatter...Azithromycin124atomsChemicalDrug:MisinformationCampaignAboutGenericBiologicsMyth:•Rawmaterialsofbiologicoriginarehardtosourceandonlybrandbiotechsknowwheretofindthem.Reality:•Rawmaterialsareavailabletodayformanygenericbiologicsincludinginsulin,G-CSF,erythropoietin,interferons,etc.MisinformationCampaignAboutGenericBiologicsMyth:•Biologicsaretoocomplicatedtobecharacterized.Reality:•Numeroushighlysophisticatedanalyticalmethodshavebeendeveloped,permittingcompletecharacterization.Moreadvanceswillbeachievedeachyear.MisinformationCampaignAboutGenericBiologicsMyth:•Genericcompanieslackthemedical,scientific,andtechnicalabilitytoproducesafeandeffectivebiotechproducts.Reality:•Genericcompaniescananddomakesafeandeffectivebiologics.ManysafeandeffectivebiologicscurrentlyaremadeincontrolledenvironmentsandmarketedbygenericcompaniesoutsidetheU.S.GenericBiologics(Biosimilars)intheEU•Theabilitytomakegenericbiol