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News From the Food and Drug Administration
September 7, 2021

First Interchangeable Biosimilar Insulin Drug Is Approved

JAMA. 2021;326(9):801. doi:10.1001/jama.2021.14729

In a move that may help make insulin more affordable for people with diabetes, the FDA has approved the first product that’s interchangeable with and biosimilar to the long-acting insulin glargine, marketed as Lantus.

The approval will allow pharmacists to substitute the biosimilar, insulin glargine-yfgn, for brand-name insulin glargine without consulting a patient’s physician, the same as they do for generic drugs. Patients’ savings could be substantial. With a discount card and no insurance coverage, the cash price of insulin glargine-yfgn is about $112 for 10 mL compared with $306 for insulin glargine.