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Generic Competition Price Drops as Number of Manufacturers Increases Market Size for Select Biologic Products Generic Biologics (Biosimilars) in the EU The ability 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 DATE Sandoz’s Omnitrope? (somatropin) April 12, 2006 BioPartners’ Valtropin? (somatropin) April 24, 2006 Sandoz’s Binocrit? Medice’s Abseamed? Hexal Biotech’s Epoetin alfa Hexal? (recombinant human erythropoietin alfa) August 28, 2007 Stada Arzneimittel’s Silapo? Hospira’s Retacrit? (epoetin zeta) December 18, 2007 Teva’s Tevagrastim? Ratiopharm’s Ratiograstim? Ratiopharm’s Filgrastim ratiopharm? CT Arzneimittel’s Biograstim? (human G-CSF) September 15, 2008 current through September 25, 2008 FDA Approves Sandoz’s Omnitrope There has been some movement in the US to approve generic biologics. FDA approved Omnitrope in May 2006. FDA stated, however, that this approval does not create a pathway for all generic biologics. Omnitrope referenced a brand product (Genotropin) approved under the FDCA. Regulatory Issues Regulatory Framework Complicated By Existence of Two Laws For Biologics FDCA for NDA Products PHSA for BLA Products NDA Products Generic Pathway Exits, But FDA Implementation Is Unclear BLA Products Three Issues Need To Be Resolved Mechanics of Approval Pathway Need To Be Defined Brand/Generic Exclusivity An Efficient Patent Dispute Resolution Mechanism Abbreviated Generic Pathway Under PHSA A Generic Pathway Should: Give FDA Authority To Decide Approval Requirements For Generic Products Adopt Exclusivity Provisions No Greater Than Those Found In Hatch-Waxman Permit Pre-Launch Adjudication of Certain Patent Disputes Abbreviated G