FDA对生物类似物的质量要求指南XXXX02

GuidanceforIndustryQualityConsiderationsinDemonstratingBiosimilaritytoaReferenceProteinProductDRAFTGUIDANCEThisguidancedocumentisbeingdistributedforcommentpurposesonly.Commentsandsuggestionsregardingthisdraftdocumentshouldbesubmittedwithin60daysofpublicationintheFederalRegisterofthenoticeannouncingtheavailabilityofthedraftguidance.SubmitcommentstotheDivisionofDocketsManagement(HFA-305),FoodandDrugAdministration,5630FishersLane,rm.1061,Rockville,MD20852.AllcommentsshouldbeidentifiedwiththedocketnumberlistedinthenoticeofavailabilitythatpublishesintheFederalRegister.Forquestionsregardingthisdraftdocumentcontact(CDER)SandraBentonat301-796-2500.U.S.DepartmentofHealthandHumanServicesFoodandDrugAdministrationCenterforDrugEvaluationandResearch(CDER)CenterforBiologicsEvaluationandResearch(CBER)February2012BiosimilarityGuidanceforIndustryQualityConsiderationsinDemonstratingBiosimilaritytoaReferenceProteinProductAdditionalcopiesareavailablefrom:OfficeofCommunicationsDivisionofDrugInformation,WO51,Room2201CenterforDrugEvaluationandResearchFoodandDrugAdministration10903NewHampshireAve.,SilverSpring,MD20993Phone:[phone];Fax:[e-mail](Tel)800-835-4709or301-827-1800(CDER)CenterforBiologicsEvaluationandResearch(CBER)February2012BiosimilarityContainsNonbindingRecommendationsDraft—NotforImplementationTABLEOFCONTENTSI.INTRODUCTION.............................................................................................................1II.BACKGROUND...............................................................................................................2III.SCOPE...............................................................................................................................4IV.DEFINITIONS..................................................................................................................5V.GENERALPRINCIPLES...............................................................................................6VI.FACTORSFORCONSIDERATIONINASSESSINGWHETHERPRODUCTSAREHIGHLYSIMILAR............................................................................................................9A.ExpressionSystem.........................................................................................................................9B.ManufacturingProcess................................................................................................................10C.AssessmentofPhysicochemicalProperties................................................................................10D.FunctionalActivities....................................................................................................................11E.ReceptorBindingandImmunochemicalProperties.................................................................12F.Impurities.....................................................................................................................................12G.ReferenceProductandReferenceStandards............................................................................13H.FinishedDrugProduct................................................................................................................14I.Stability.........................................................................................................................................15VII.CONCLUSION...............................................................................................................15VIII.RELEVANTGUIDANCES...........................................................................................16510152025303540ContainsNonbindingRecommendationsDraft—NotforImplementation1GuidanceforIndustry12QualityConsiderationsinDemonstratingBiosimilaritytoa3ReferenceProteinProduct467Thisdraftguidance,whenfinalized,willrepresenttheFoodandDrugAdministration's(FDA's)current8thinkingonthistopic.Itdoesnotcreateorconferanyrightsfororonanypersonanddoesnotoperateto9bindFDAorthepublic.Youcanuseanalternativeapproachiftheapproachsatisfiestherequirementsoftheapplicablestatutesandregulations.Ifyouwanttodiscussanalternativeapproach,contacttheFDA11staffresponsibleforimplementingthisguidance.IfyoucannotidentifytheappropriateFDAstaff,call12theappropriatenumberlistedonthetitlepageofthisguidance.131416I.INTRODUCTION1718ThisguidancedescribestheAgency’scurrentthinkingonfactorstoconsiderwhen19demonstratingthataproposedproteinproductishighlysimilartoareferenceproductlicensedundersection351(a)ofthePublicHealthServiceAct(PHSAct)forpurposesofsubmittinga21marketingapplicationunde