FDA approves Semglee as first biosimilar interchangeable insulin

Regulatory NewsRegulatory News | 28 July 2021 |  By 

The US Food and Drug Administration (FDA) has approved the first interchangeable biosimilar product, giving the designation to a once-daily insulin product to treat diabetes.
FDA’s designation of Semglee (insulin glargine-yfgn, Mylan) as interchangeable with Lantus (insulin glargine, Sanofi) means that Semglee may now be substituted for the reference product at the pharmacy “without the intervention of the prescriber,” noted FDA in a Wednesday evening press release announcing the shift in status for Semglee.
“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.”
Allowing pharmacy-level substitution for this long-acting insulin has the promise of reducing the cost for a medicine used to improve glycemic control in millions of the 34 million people in the US who have been diagnosed with Type 1 or Type 2 diabetes. The price of insulin in the US has risen sharply over the last decade, even as the incidence of Type 2 diabetes has continued an upward climb.
“Biosimilars marketed in the US typically have launched with initial list prices 15% to 35% lower than comparative list prices of the reference products,” wrote FDA in announcing Semglee’s change in regulatory status. (RELATED: Where are the Interchangeable Biosimilars?, Regulatory Focus 21 October 2019)
Interchangeable biosimilars must be assessed by FDA as being highly similar to their reference product, with no clinically meaningful differences in safety, purity or potency. Also, the same clinical result should be expected from use of either the interchangeable biosimilar or its reference product, with no difference in expected outcome between a patient who switched to Semglee from Lantus, compared to a patient who remained on Lantus for glycemic control.
Semglee was first approved as a human insulin analog in June 2020. FDA has released new material for health care providers to help them learn about interchangeable biosimilar products, including a new fact sheet dedicated to explaining the concept of an interchangeable biosimilar.


© 2023 Regulatory Affairs Professionals Society.

Discover more of what matters to you