FDA生物类似物问答XXXX02

GuidanceforIndustryBiosimilars:QuestionsandAnswersRegardingImplementationoftheBiologicsPriceCompetitionandInnovationActof2009DRAFTGUIDANCEThisguidancedocumentisbeingdistributedforcommentpurposesonly.Commentsandsuggestionsregardingthisdraftdocumentshouldbesubmittedwithin60daysofpublicationintheFederalRegisterofthenoticeannouncingtheavailabilityofthedraftguidance.SubmitcommentstotheDivisionofDocketsManagement(HFA-305),FoodandDrugAdministration,5630FishersLane,rm.1061,Rockville,MD20852.AllcommentsshouldbeidentifiedwiththedocketnumberlistedinthenoticeofavailabilitythatpublishesintheFederalRegister.Forquestionsregardingthisdraftdocumentcontact(CDER)SandraBentonat301-796-2500or(CBER)OfficeofCommunication,OutreachandDevelopmentat1-800-835-4709or301-827-1800.U.S.DepartmentofHealthandHumanServicesFoodandDrugAdministrationCenterforDrugEvaluationandResearch(CDER)CenterforBiologicsEvaluationandResearch(CBER)February2012BiosimilarityGuidanceforIndustryBiosimilars:QuestionsandAnswersRegardingImplementationoftheBiologicsPriceCompetitionandInnovationActof2009Additionalcopiesareavailablefrom:OfficeofTrainingandCommunicationDivisionofDrugInformation,HFD-240CenterforDrugEvaluationandResearchFoodandDrugAdministration5600FishersLaneRockville,MD20857(Tel)301-827-4573://(Tel)800-835-4709or301-827-1800U.S.DepartmentofHealthandHumanServicesFoodandDrugAdministrationCenterforDrugEvaluationandResearch(CDER)CenterforBiologicsEvaluationandResearch(CBER)February2012BiosimilarityTABLEOFCONTENTSINTRODUCTION.........................................................................................................................1BACKGROUND...........................................................................................................................2QUESTIONSANDANSWERS...................................................................................................4I. BIOSIMILARITYORINTERCHANGEABILITY...........................................................4II. PROVISIONSRELATEDTOREQUIREMENTTOSUBMITABLAFORA“BIOLOGICALPRODUCT”...........................................................................................12III. EXCLUSIVITY................................................................................................................15ContainsNonbindingRecommendationsDraft—NotforImplementationGuidance1Biosimilars:QuestionsandAnswersRegardingImplementationoftheBiologicsPriceCompetitionandInnovationActof2009Thisdraftguidance,whenfinalized,willrepresenttheFoodandDrugAdministration’s(FDA’s)currentthinkingonthistopic.ItdoesnotcreateorconferanyrightsfororonanypersonanddoesnotoperatetobindFDAorthepublic.Youcanuseanalternativeapproachiftheapproachsatisfiestherequirementsoftheapplicablestatutesandregulations.Ifyouwanttodiscussanalternativeapproach,contacttheFDAstaffresponsibleforimplementingthisguidance.IfyoucannotidentifytheappropriateFDAstaff,calltheappropriatenumberlistedonthetitlepageofthisguidance.INTRODUCTIONThisguidanceprovidesanswerstocommonquestionsfromsponsorsinterestedindevelopingproposedbiosimilarproducts,biologicslicenseapplication(BLA)holders,andotherinterestedpartiesregardingFDA’sinterpretationoftheBiologicsPriceCompetitionandInnovationActof2009(BPCIAct).Thequestionsandanswers(Q&As)aregroupedbelowinthefollowingcategories:BiosimilarityorInterchangeabilityProvisionsRelatedtoRequirementtoSubmitaBLAfora“BiologicalProduct”ExclusivityTheBPCIActamendsthePublicHealthServiceAct(PHSAct)andotherstatutestocreateanabbreviatedlicensurepathwayinsection351(k)ofthePHSActforbiologicalproductsshowntobebiosimilarto,orinterchangeablewith,anFDA-licensedbiologicalreferenceproduct(seesections7001through7003ofthePatientProtectionandAffordableCareAct(Pub.L.111–148)(AffordableCareAct)).OnNovember2and3,2010,FDAheldapublichearingandestablishedapublicdockettoobtaininputonspecificissuesandchallengesassociatedwiththeimplementationoftheBPCIAct(seeDocketNo.FDA-2010-N-0477).ThisguidancedescribesFDA’scurrentinterpretationofcertainstatutoryrequirementsaddedbytheBPCIActandreflectsconsiderationofthecommentsconcerningthoserequirementsthatweresubmittedtothepublicdocket.1ThisguidancehasbeenpreparedbytheCenterforDrugEvaluationandResearch(CDER)andtheCenterforBiologicsEvaluationandResearch(CBER)attheFoodandDrugAdministration(FDAortheAgency).GuidancedocumentsareavailableontheCDERguidancepageat—NotforImplementationThisguidanceisoneinaseriesofguidancesthatFDAisdevelopingtoimplementtheBPCIAct.Theguidance