similar to how generic drugs have reduced costs. Biosimilars marketed in the US typically have launched with initial list prices 15% to 35% lower than comparative list prices of the reference products," the FDA notes in their statement.
"This is a momentous day for people who rely daily on insulin for treatment of diabetes, as biosimilar and interchangeable biosimilar products have the potential to greatly reduce health care costs," said Acting FDA Commissioner Janet Woodcock, M.D. "Today's approval of the fi...
An interchangeable biosimilar may be substituted at the pharmacy for the reference product without the intervention of the prescribing healthcare provider, depending on state pharmacy laws. Not all biosimilars are interchangeable. An interchangeable designation is granted by the FDA to only tho...
FDA previously provided recommendations for postapproval manufacturing changes to biosimilars as part of a September 2021 final guidance. The agency did not include recommendations for postapproval manufacturing changes to interchangeable biosimilars at that time. The agen...