title: Study design is important for ESA biosimilars.
abstract: U.S. regulations require biosimilars to be highly similar to their reference product and demonstrate no clinically meaningful differences in safety, purity, or potency. For biosimilars of erythropoiesis-stimulating agents (ESAs), this standard is challenging--structural differences are likely, and their effect on safety and efficacy cannot be predicted from analytical studies. Thus, clinical trials should compare hemoglobin, dose, and immunogenicity endpoints.
authors.forename: Allan
authors.initials: A
authors.lastname: Pollock
authors.forename: Gustavo
authors.initials: G
authors.lastname: Grampp
mesh_terms: D059451:Biosimilar Pharmaceuticals; D002986:Clinical Trials as Topic / Q000379:methods*; D017408:Guidelines as Topic; D006397:Hematinics; D006801:Humans; D012107:Research Design
chemical_list: D059451:Biosimilar Pharmaceuticals; D006397:Hematinics