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FDA redefines insulin as a 'biologic.' Here's why that's a big deal.


FDA last week published a final rule that classifies insulin as a biologic product, a move that the agency says could increase market competition and lower the cost of the drug.

Insulin prices skyrocket in the U.S.

According to a report from the Healthcare Cost Institute, per-person spending on insulin for patients with Type 1 diabetes doubled between 2012 and 2016. Even for patients with health insurance, out-of-pocket insulin costs can reach $1,000 per month.

The sudden cost increase has sparked concerns among patients and Congress about patients' access to the life-saving drug. In response, federal lawmakers have launched investigations into rising insulin prices and have called for measures to expedite FDA approval of new insulin products.

Some U.S. health insurers and states also have taken action to curb patients' insulin costs.

FDA redefines biologics

FDA on Feb. 20 published a final rule that updates the definition of the term "biological product" to include insulin, which currently is approved and regulated as a chemical drug, and about 90 other products.

Under the final rule, a "biological product" will now include all "proteins," which the rule defines as "any alpha amino acid polymer with a specific, defined sequence that is greater than 40 amino acids in size." FDA noted that it made those changes in alignment with those made by Congress in the Biologics Price Competition and Innovation Act of 2009 and the Further Consolidated Appropriations Act, 2020.

The change means that applications for biosimilar versions of insulin and the dozens of other affected products will be transferred to biologics license applications.

The rule is set to take effect March 23.

FDA Commissioner Stephen Hahn in the release said the move "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," which "is expected to bring down prices and help patients have access to more choices for these lifesaving drugs."

The agency also published two frequently asked question documents that explain how patients and health care providers may be affected by the transition. In the documents, FDA explains the transition should not impact existing prescribing or dispensing practices, meaning patients should be able to continue taking their current medications (Anderson, Becker's Hospital Review, 2/21; Healio, 2/20; Mezher, RAPS, 2/20; Lee, Bloomberg Law, 2/20).

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