The change allows drugmakers to manufacture biosimilar versions of insulin, lower-cost versions of the drug that have the same clinical effects.
The FDA said it hopes the move will increase patient access to insulin.
“Opening these products to increased competition is expected to bring down prices and help patients have access to more choices for these lifesaving drugs,” said FDA Commissioner Stephen Hahn, MD.
The FDA published the final rule classifying insulin as a biologic product Feb. 20 as well as documents with frequently asked questions to explain the transition to patients and providers.
Read the full news release here.
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