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- W1170065891 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." @default.
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- W1170065891 date "2015-11-01" @default.
- W1170065891 modified "2023-09-23" @default.
- W1170065891 title "Study design is important for ESA biosimilars." @default.
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