Forward Steps in the Generic ADF Lifecycle

Transcription

1 Frward Steps in the Generic ADF Lifecycle 1

2 BACKGROUND Generic prducts nw accunt fr 89% f US prescriptins As new abuse deterrent frmulatins are apprved fr brand prducts, there shuld be apprpriate FDA guidance available fr the develpment f the generic prduct 2014 FDA held public meeting abut the then draft guidance Abuse Deterrent Opiids- Evaluatin and Labeling and asked input frm generic industry 2015 FDA issued final guidance Abuse Deterrent Opiids Evaluatin and Labeling 2016 FDA issued draft guidance General Principles fr Evaluating the Abuse Deterrence f Generic Slid Oral Opiid Drug Prducts 2

3 BACKGROUND CONT.. Currently, there are n FDA apprved ADF piid generics The current draft guidance requires further clarity n FDA s requirements fr a generic t develp the data fr submissin f an ANDA The draft guidance must be revised, reissued fr public cmment, and then finalized expeditiusly FDA issuance f Prduct Specific Guidance shuld be in clse prximity t the RLD apprval 3

4 GENERIC GUIDANCE WARRANTS CLARITY REGULATORY Prvisin f cnsistent guidance acrss ANDAs t ensure hmgeneity f generic ADF prducts GDUFA II establishes a regulatry pathway fr cmplex ANDAs Cmplex ANDA prcess will create additinal cmmunicatin venues t discuss prgram with FDA beynd traditinal cntrlled crrespndence As lng as an ANDA cntains apprpriate studies fr ADF, it shuld be accepted fr filing Pririty review ptential fr generic ADF spnsrs in GDUFA II Classificatin f ADF generics as a Cmplex Prduct per GDUFA II alngside prgram prvisins assciated Refine Draft Guidance such that nmenclature is analgus and rdered t that f the brand Final Guidance 4

5 LEGAL POLICY Need clarity n cnditins f apprval f brand & incremental imprvement t ensure ever greening des nt ccur preventing develpment & apprval f generic ADF ptins STUDIES/TECHNOLOGIES/ANALYSES Need guidance n immediate release (IR) prducts & current/newer technlgies that d nt rely n excessive hardness (resistance t crush) Need t address the number f test units testing r statistical pwer t detect a specified difference shuld be perfrmed n and, ideally this shuld be standardized Need statistical principles described t ensure inherent analytical variability within a methd is prperly accunted fr 5

6 GENERIC GUIDANCE WARRANTS CLARITY (CONT) STUDIES/TECHNOLOGIES/ANALYSES (cnt.) Need dedicated sectins n the required in-vitr studies included in prduct-specific guidance Need clarity n when a PK r PD studies may be required and include in general guidance and details f the required study(ies) in prduct-specific guidance When pssible the Cntrl shuld be same as used fr RLD. When nt, details shuld be included in prduct specific guidance Need FDA t develp acceptance criteria fr the in-vitr and the PK studies Expect ne-sided (e.g., n wrse than) 6

7 GENERIC GUIDANCE WARRANTS CLARITY (CONT) STUDIES/TECHNOLOGIES/ANALYSES (cnt.) Demnstratin f AD prperties wuld nly be perfrmed against the RLD In vitr methds are used t verify that the suitability f nn-dsing strengths Evaluatin f the drug prduct s AD perfrmance wuld nt be part f rutine QC testing Spnsr demnstrates significant frmulatin/prcess understanding during prduct develpment Requires apprpriate release testing f key AD excipients prir t manufacture 7

8 ASSUMPTIONS Categry 1 (in vitr) mandatry, categry 2 (pk) and categry 3 (HAL) studies based n the science f the RLD: Examples When the Categry 1 and Categry 2 testing are predictive (crrelatin exists r can be established) f Categry 3, then nly Categry 1/Categry 2 testing wuld be needed If the Categry 1 and Categry 2 are nt predictive (crrelatin des nt exist r cannt be established) f Categry 3, then Categry 3 wuld be required This wuld be explained in a prduct specific guidance. Platfrm apprach which leverages multiple drug prducts ver a range f strengths Generic ADF piids will nt be subject t pst marketing cmmitments (PMC) r requirements (PMR) Sectin 9 labeling t be cmparable t brand (n carve-uts) Generic ADF piids will be recgnized as therapeutically equivalent in the Orange Bk 8

9 THE VALUE OF PRODUCT SPECIFIC GUIDANCE GDUFA II categrizes ADF generics as Cmplex Prducts and prvide prvisins assciated with it Prduct develpment meetings assciated with Cmplex Prducts Pre-submissin meeting shuld be vehicle t facilitate spnsr FDA discussin and agreement n develpment plan including deviatins frm guidance when apprpriate With advances in technlgy prduct might nt be cmparable in size, shape, and ther attributes (per FDA guidance June 2015) 9

10 THE VALUE OF PRODUCT SPECIFIC GUIDANCE (CONT) Prduct Specific Guidance fr generic ADF prduct shuld be issued within 30 days f apprval f innvatr Via private meeting with generic manufacturers r ther mechanism t ensure safety f public Cnsistent with the abuse deterrent attributes described fr the RLD in the label Referring t the studies in bth the general and prduct specific guidance in an analgus manner t that f the brand guidance (i.e., categry 1, categry 2, categry 3) wuld be helpful 10

11 CONCLUSION The Generics Industry Wrking Grup Recmmendatins are: Generic ADF piids will be cnsidered Cmplex Prducts and included in the pre-anda prgram Enhanced pathway fr Cmplex Prducts benefits including prduct develpment meetings, pre-submissin meetings, and mid-review cycle meetings Categry 1 mandatry, Categry 2 and Categry 3 required as needed fr generic ADF piids Categry 2 and Categry 3 will be required based n the scientific prperties f the RLD FDA develp plicy t ensure n ever greening will ccur blcking generic ADF FDA revise Draft Guidance reflecting recmmendatins identified by GIWG and issue Prduct Specific Guidance timely 11