Streamlined approval of biosimilars: moving on from the confirmatory efficacy trial
Marie-Christine Bielsky, Anne Cook, Andrea Wallington, Andrew Exley, Shahin Kauser, Justin L. Hay, Leonard Both, David T. Brown
Topics & Concepts
BiosimilarComparabilityClinical trialMedicineBlueprintBiopharmaceuticsEuropean unionPharmacovigilancePharmacologyMedical physicsIntensive care medicineRisk analysis (engineering)BusinessAdverse effectInternal medicineEngineeringChemistryEconomic policyMathematicsIn vitroPharmacognosyCombinatoricsBiochemistryBiological activityMechanical engineeringBiosimilars and Bioanalytical MethodsPharmaceutical Economics and PolicyPharmaceutical studies and practices