1. A sense of déjà vu: the debate surrounding state biosimilar substitution laws Author(s): Purvis, Leigh, author Publication: Washington, D.C. : AARP Public Policy Institute, September 2014 Subject(s): Biological Products -- economicsBiological Products -- therapeutic useBiosimilar Pharmaceuticals -- economicsBiosimilar Pharmaceuticals -- therapeutic useDrug CostsDrug SubstitutionLegislation, DrugDrugs, Generic -- economicsFederal GovernmentState GovernmentHumansUnited StatesUnited States. Food and Drug Administration.United States.
2. Considerations in demonstrating interchangeability with a reference product Publication: Silver Spring, MD : Center for Drug Evaluation and Research, May 2019 Subject(s): Biosimilar Pharmaceuticals -- standardsDrug SubstitutionProteins -- therapeutic useBiological ProductsClinical Trials as TopicResearch DesignHumansUnited StatesUnited States. Department of Health and Human Services.United States. Food and Drug Administration.
