Follow-On Biologics_ Economic, Innovation and Policy Reflections.ppt

follow-on biologics: economic, innovation and policy reflections the fuqua school of business duke 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 generic biologics commercial opportunities mandatory clinical trials; requirement that generics seek approval for all approved brand uses. abbreviated generic pathway under phsa congress should carefully consider any new, additional exclusivities awarded to brand biologics. considerable incentives already exist for brand biotech companies. existing incentives for brand biotech companies incentive patent term restorationdrug manufacturers get back up to 5 years of time lost to product testing and approval delays. pto patent restorationif the patent approval is delayed by ptos fault, patentee gets back each day in excess of 3 years. orphan drug exclusivity7 years of exclusivity for drugs treating rare diseases. general business r likely to be on legislative agenda in 2009 strong consensus for generic biologics among payers, consumer groups debate centers on three issues mechanics of pathway how to resolve ip issues exclusivity issue state governors broad, bipartisan support for a workable pathway for generic biologics groups in supportgroups in opposition consumer groups aarp afl-cio afscme california public employees retirement system (calpers) consumer federation of america consumers union families usa national consumers league national multiple sclerosis society (ms) national research center for women & families national organization for rare disorders (nord) national womens health network pharmaceutical care management public citizen service employees international union (seiu) spastic paraplegia foundation us public interest research group united auto workers (uaw) bio phrma business groups caterpillar, inc. daimlerchrysler corporation eastman kodak company ford motor company general motors corporation health plans aetna inc. americas health insurance plans blue cross blue shield association humana kaiser permanente united health group wellpoint pharmaceutical stakeholders apotex ben venue barr laboratories caremark express scripts generic pharmaceutical association (gpha) hospira medco momenta national association of chain drug stores national association of health underwriters pharmaceutical care management association (pcma) ranbaxy pharmaceuticals sandoz teva pharmaceuticals usa watson pharmaceuti