FDA Approves Insulin Glargine-yfgn as First Interchangeable Biosimilar Insulin Product for Diabetes


Officials with the FDA have approved the first interchangeable biosimilar insulin product for patients with type 1 or type 2 diabetes mellitus. Insulin glargine-yfgn (Semglee) is biosimilar to and interchangeable with insulin glargine (Lantus), a long-acting insulin analog.

An interchangeable biosimilar can be substituted for the reference product by pharmacists without prescriber intervention. Insulin glargine-yfgn is the first interchangeable biosimilar product for the treatment of diabetes approved in the United States, which can provide patients with alternative, equally effective options for treating diabetes that could be more cost effective.

“This is a momentous day for people who rely daily on insulin for treatment of diabetes, as biosimilar and interchangeable biosimilar products have the potential to greatly reduce health care costs,” said Janet Woodcock, MD, acting FDA commissioner, in a press release. “Today’s approval of the first interchangeable biosimilar product furthers FDA’s longstanding commitment to support a competitive marketplace for biological products and ultimately empowers patients by helping to increase access to safe, effective and high-quality medications at potentially lower cost.”

According to the FDA, the approval of insulin glargine-yfgn as an interchangeable biosimilar to insulin glargine is based on evidence that there are no clinically meaningful differences between the 2 products in terms of safety, purity, and effectiveness. It has also been demonstrated that insulin glargine-yfgn can be expected to produce the same clinical result as insulin glargine in any given patient, with no greater risk of diminished efficacy or difference in safety when switching to insulin glargine-yfgn from insulin glargine when compared to the continued use of insulin glargine without switching.

“Access to affordable insulin is critical and long-acting insulin products, like insulin glargine, play an important role in the treatment of types 1 and 2 diabetes mellitus,” said Peter Stein, MD, director of the Office of New Drugs in the FDA’s Center for Drug Evaluation and Research, in the release. “The FDA’s high standards for approval mean health care professionals and patients can be confident in the safety and effectiveness of an interchangeable biosimilar product, just as they would for the reference product.”


FDA approves first interchangeable biosimilar insulin product for treatment of diabetes [news release]. FDA; July 28, 2021. Accessed July 29, 2021. https://www.fda.gov/news-events/press-announcements/fda-approves-first-interchangeable-biosimilar-insulin-product-treatment-diabetes

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