An exciting new potential for interchangeable insulin products that can be substituted for branded insulin as a result of new FDA biosimilars policies. Under the Biologics Price Competition and Innovation Act of 2009 (BPCI Act), biologics (such as insulin) that have been approved under NDAs (drugs) will be deemed on March 23, 2020, to be approved under BLAs (biologics). This change could potentially drive down the cost of insulin which means increased access to insulin. To learn about this exciting news, please click below.
https://www.biocentury.com/bc-extra/politics-policy/2018-12-11/fda-biosimilars-policies-will-bring-interchangeable-insulin-
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