FollowOn Biologics Economic, Innovation and Policy Reflections.ppt
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1、Follow-On Biologics:Economic,Innovation and Policy Reflections The Fuqua School of BusinessDuke University,November 6-7,2008,Charles DiLiberti,V.P.Global Pharmacokinetics and Bioequivalence,Barr Laboratories,Inc.,“Commercial Opportunities and Challenges for Follow-on Biologics”,Presentation Overview
2、,Generic BiologicsCommercial Opportunities&SavingsScience&Technology ChallengesRegulatory&Intellectual Property IssuesSummary,Commercial Opportunities&Savings,Benefits of Generic Competition,Significant Cost Saving OpportunitiesSavings for consumers and taxpayersGeneric Competition Will Fuel Innovat
3、ionBrand companies will have the incentive needed to vigorously pursue new biologics,Increasing Significance of Biologic Products,US Biologic Revenues1997:$17.4 Billion2007:$65.2 Billion*400 Biologics&Vaccines Currently in Clinical Trials Targeting 200 Diseases*Between 2003 and 2006,biologics repres
4、ented 24%of all new chemical entities approved by the US*Sales of biotech products in the US showed an annual growth rate of 20%between 2001 and 2006 compared with 6%to 8%in the pharmaceutical market*,*Ernst&Young*Biotechnology Industry Organization*Journal of American Medical Association,October 22
5、,2008,High Cost of Brand Biologics,Annual Cost per Patient Enbrel(Arthritis)$20,000*Cerezyme(Gaucher Disease)$200,000*Remicade(Arthritis)$35,000-$66,000*Generic Competition Will Reduce These Costs,*Baltimore Sun January 28,2007*Bloomberg January 11,2007*Philadelphia Inquirer September 19,2006,Signif
6、icant Cost Savings Opportunity,Generic Biologics Represent Significant Cost Savings Opportunities and Stimulate Innovation,EpogenMarket Before Generic Launch:$2.5 Billion*Brand/Year Today:$9,000*Generic Savings/Year assuming 50%savings:$4,500,EnbrelMarket Before Generic Launch:$2.7 Billion*Brand/Yea
7、r Today:$20,000*Generic Savings/Year assuming 50%savings:$10,000,*ABN AMRO February 2008*National Journal February 10,2007*Baltimore Sun January 28,2007,Generic Competition,Price Drops as Number of Manufacturers Increases,Market Size for Select Biologic Products,Source:ABN AMRO February 2008,Market
8、Size for Select Biologic Products,Source:ABN AMRO February 2008,Perspective:Historical Growth in Substitution,Source:IMS Health,Banc of America Securities LLC estimates,Generic BiologicsOpportunity,Generic Pharmaceuticals-A Vital Part in Health Care SystemApproximately 67%of the Prescriptions Dispen
9、sed in the US Are Generics*BiologicsWorldwide Market Estimated around$75 Billion*Per Patient Cost for Biologic Products Can Exceed$100,000 Per Year Generic BiologicsUS Consumers Could Save$43 Billion Between 2011 and 2020*Estimated Value of Biologics that have already lost Patent Protection:$10 Bill
10、ion*Estimated Value of Biologics to lose Patent Protection in the Next Ten Years:$20 Billion*,*IMS Health*Citizens Against Government Waste(CAGW)Release,May 2,2007*ABN AMRO February 2008,Science&Technology Challenges,Scientific Challenges for Generic Biologics,CharacterizationSafety AssessmentTherap
11、eutic EquivalenceManufacturing Controls,Generic Biologics,Generic biologics,sometimes called follow-on biologics(FOBs),are protein products that are pharmaceutically and therapeutically equivalentGeneric biologics do not utilize the reference products proprietary process,specifications or clinical d
12、ata For established products,therapeutic equivalence can be demonstrated usingIn vitro studies and/orPharmacokinetics and/orSurrogate markers and/orClinical outcomesdepending on the characteristics of the protein,Biologics Size Does Matter.,Misinformation Campaign About Generic Biologics,Myth:Raw ma
13、terials of biologic origin are hard to source and only brand biotechs know where to find them.Reality:Raw materials are available today for many generic biologics including insulin,G-CSF,erythropoietin,interferons,etc.,Misinformation Campaign About Generic Biologics,Myth:Biologics are too complicate
14、d to be characterized.Reality:Numerous highly sophisticated analytical methods have been developed,permitting complete characterization.More advances will be achieved each year.,Misinformation Campaign About Generic Biologics,Myth:Generic companies lack the medical,scientific,and technical ability t
15、o produce safe and effective biotech products.Reality:Generic companies can and do make safe and effective biologics.Many safe and effective biologics currently are made in controlled environments and marketed by generic companies outside the U.S.,Generic Biologics(Biosimilars)in the EU,The ability
16、to make generic biologics is far from a theoretical possibility.In 2004 EU issued EMEA Draft Guidelines for four classes of generic biologics,referred to as biosimiliars in the EU.Since 2004,the EU has approved several biosimilar products.,EU Biosimilar Approvals,DRUG EU MARKET AUTHORIZATION DATESan
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