FDA Approves Interchangeable Biosimilar Insulin

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FDA has approved Mylan Pharmaceuticals’ Semglee, the first interchangeable biosimilar insulin product for treating diabetes.

On July 28, 2021, FDA approved Mylan Pharmaceuticals’ Semglee (insulin glargine-yfgn), the first interchangeable biosimilar insulin product in the United States for treating diabetes. The product is indicated for improving glycemic control in adults and pediatric patients with Type 1 diabetes mellitus and in adults with Type 2 diabetes mellitus. Semglee is both biosimilar to and interchangeable with its reference product, Lantus (insulin glargine), a long-acting insulin analog.

According to FDA, an interchangeable biosimilar product may be substituted for the reference product and does not require the intervention of a prescriber. Substitution may occur at pharmacy level, similar to how generic drugs are substituted for brand name drugs, subject to state pharmacy laws, which vary by state. Similar to generic-drug cost savings, biosimilar and interchangeable biosimilar products have the potential to reduce health care costs. Biosimilars marketed in the US have typically launched at initial list prices that are 15% to 35% lower than comparative list prices of the reference product, the agency stated in a press release.

The approval of Semglee is based on evidence that showed it is highly similar to the reference product, Lantus, and that there are no clinically meaningful differences between the two in terms of safety, purity, and potency. Evidence also showed that Semglee can be expected to produce the same clinical result as Lantus and that the safety and efficacy risks in switching from Lantus to Semglee are no greater than the risks of using Lantus without switching.

“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 Acting FDA Commissioner Janet Woodcock in the 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.”


“Access to affordable insulin is critical, and long-acting insulin products, [such as] insulin glargine, play an important role in the treatment of Types 1 and 2 diabetes mellitus,” said Peter Stein, director of the Office of New Drugs in FDA’s Center for Drug Evaluation and Research. “[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.”

Source: FDA