携手合作提升仿制药的可及性.pdf

1、Working Together to Increase Access to Generic DrugsDarby Kozak,PhDDeputy Director Office of Generic Drugs|CDER|U.S.FDAGeneric Drugs ForumApril 9,2025Agenda State of the Generic Drug Program 2024 Abbreviated New Drug Application(ANDA)Approvals A Notable 2024 First Generic:Bupivacaine Liposomal Injec

2、tion How research and guidance translates to generic access Facilitating Access to Generic Drugs:Initiatives and Efforts Increased Transparency Pilot for ANDAs with Missed Goal Dates Bioequivalence Study Protocol Review Product Development Meetings Helpful Webinars and Other Resources for Generic Dr

3、ug Manufacturers Importance of Data Integrity2www.fda.govThe Value of Generic Drugs Substitutable for brand-name drugs Held to the same rigorous FDA quality standards as brand-name drugs Increase patient and consumer access to needed treatment through diverse manufacturers,increased production,wider

4、 availability,and mitigation of shortages3www.fda.govState of the Generic Drug Program:GDUFA Accelerates Access to Generic Drugs4www.fda.govState of the Generic Drug Program:Generic Approvals 2024 Calendar Yearapproved or tentatively approvedapproved or tentatively approved First Generic Drug Approv

5、als First Generic Drug ApprovalsCompetitive Generic Therapy Competitive Generic Therapy 900 ANDAs 900 ANDAs approved or tentatively approved or tentatively approvedapproved,including:,including:7676 First GenericDrug Approvals132132 generics with Competitive Generic Therapy designation9292 complexge

6、nerics5www.fda.govNotable First Generic:Bupivacaine Liposomal InjectionHow Research and Guidance Translates to Generic Access6Oct 28,2011Approval of Reference Listed Drug,Exparel,a locally acting complex multivesicular liposomal injection for post-surgical,non-opioid pain managementNov 2016Initiatio