1. 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.
