The Food and Drug Administration (FDA) published a final rule on February 21 that the agency hopes will increase patients access to insulin and some other biologic products.
The final rule “will open new pathways for manufacturers to bring biosimilar and interchangeable versions of insulin and other transitioning products to market, facilitating greater competition in the marketplace,” said FDA Commissioner Stephen M. Hahn, MD. “These critical therapies often carry a heavy price tag; the cost of insulin has risen over the past decade. Opening these products to increased competition is expected to bring down prices and help patients have access to more choices for these life-saving drugs.”
Specifically, the regulation transitions insulin and human growth hormone from being classified as prescription drugs to biologics, such as vaccines, meaning that they now will be regulated by the Public Health Service Act rather than by the Federal Food, Drug, and Cosmetic Act.
“As such, the transition of insulin products from approved drug applications to deemed biological product licenses will open up those products to potential biosimilar and interchangeable competition,” the FDA said in a statement.
The final rule, “Definition of the Term ‘Biological Product,’” amends the FDA’s regulation that defines “biological product” to incorporate changes made by the Biologics Price Competition and Innovation Act of 2009 (BPCI Act) and the Further Consolidated Appropriations Act, 2020, and to codify the FDA’s interpretation of the statutory term “protein.” Under this interpretation, the term “protein” means any alpha amino acid polymer with a specific, defined sequence that is greater than 40 amino acids in size. This interpretation is intended to clarify the statutory framework under which such products are regulated.
