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EMA/HMA joint statement on the scientific rationale supporting interchangeability of biosimilar medicines in the EU

European Journal of Hospital Pharmacy · 2022 · 32 citations · 0 references

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PharmacyPharmacologyBioequivalenceBioequivalence RegulationPharmacovigilanceBioequivalence AssessmentBioequivalence RequirementsBiosimilar RegulationDrug CompatibilityReference Product ComparisonRegulatory Documentation For BioequivalenceCross-jurisdictional Substitution RulesInterchangeability RulesInternational Reference Product HarmonizationNaming Conventions For BiosimilarsPharmacovigilance For BiosimilarsRegulatory Bioequivalence CriteriaScientific Rationale Requirement