Current Opinion in Hematology (11/07/2015) Schulz, M.; Bonig, H.

The approval of the first biosimilar granulocyte colony-stimulating factor (G-CSF) in the United States calls for an examination of new insights into biosimilar G-CSF and attempts to project the future of biosimilars. Much of the recent literature on biosimilar G-CSF focuses on patient access and its effects on healthcare spending. The approval and introduction of biosimilar G-CSF have led to surprising price reductions for short-acting G-CSF. These price reductions could put the economic viability of biosimilar programs at risk. "On the clinical side, little excitement is tangible, probably appropriately so, since clinical data indicate nothing short of biological similarity," researchers from Goethe University and University of Washington report. They note that although there have been few formal clinical trials, there are many case series and historic comparisons that demonstrate the appropriateness of considering biosimilar G-CSF to be biologically similar to the originator.

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