Analytical similarity assessment in biosimilar product development

Content: IntroductionBackgroundPast Experience for In Vitro Bioequivalence TestingAnalytical Similarity AssessmentScientific Factors and practical issuesAim and Scope of the BookRegulatory Approval Pathway of Biosimilar ProductsIntroductionRegulatory requirementsAnalytical Studies for Functional/Structural CharacterizationGlobal harmonizationConcluding remarksCMC RequirementsIntroductionCMC DevelopmentManufacturing Process ValidationQuality Control and Assurance Stability AnalysisConcluding RemarksAssay Development and Process ValidationIntroductionRegulatory RequirementsAnalytical Method ValidationAnalysis of Validation DataEvaluation of Reliability, Repeatability, and ReproducibilityConcluding remarks Critical Quality AttributesIntroductionIdentification of CQAsClassification of CQAsConcluding RemarksFDA Tiered Approach for Analytical AssessmentBackgroundStepwise ApproachTier Equivalence TestOther tiered approachesSome Practical ConsiderationsConcluding Remarks Sample Size RequirementIntroductionTraditional ApproachFDA\'s Current Thinking and RecommendationSample Size RequirementNumerical StudiesConcluding remarksMultiple ReferencesBackgroundMethod of Pairwise ComparisonsSimultaneous Confidence Interval Reference Product ChangeConcluding remarksExtrapolation Across IndicationsIntroductionAn ExampleDevelopment of Sensitivity IndexAssessment of Sensitivity Index Statistical Inference of Extrapolation Concluding RemarksCase Studies - FDA SubmissionsFDA Abbreviated Licensure PathwaySponsor\'s Strategy for Regulatory SubmissionAvastin Biosimilar Regulatory Submission Herceptin Biosimilar Regulatory SubmissionConcluding RemarksPractical and Challenging IssuesIntroductionHypotheses versus Confidence Interval ApproachTotality-of-the-evidence Inconsistencies Between Tired ApproachesIndividual bioequivalenceCommonly Asked Questions from the SponsorsConcluding RemarksRecent Development           Introduction           Comparing Means versus Comparing Variances            Switching Design            Non-Medical Switching           FDA guidance on Analytical Similarity Assessment           Concluding Remarks