First Interchangeable Biosimilar Insulin Approved by FDA for Diabetes

The FDA has approved the first interchangeable biosimilar insulin product, insulin glargine-yfgn (Semglee; Mylan Pharmaceuticals), for children and adults with type 1 diabetes and adults with type 2 diabetes.

A biosimilar is a biological product that is highly similar to a biological product already approved by the FDA. An interchangeable biosimilar may be substituted for the reference product at the pharmacy level.

This biosimilar can be used in place of its reference product insulin glargine (Lantus; Sanofi), a long-acting insulin analog. A sub-group of human insulin, analog insulin is laboratory-grown but genetically altered to create either a more rapid-acting or uniformly acting form of the insulin. This can have advantages for blood sugar management.¹

The approval of insulin glargine-yfgn as an interchangeable biosimilar to insulin glargine is based on evidence that showed the products are highly similar and that there are no clinically meaningful differences in terms of safety, purity, and potency. Insulin glargine-yfgn can be expected to produce the same clinical result as the reference product in any given patient with no additional safety risks.

Insulin glargine-yfgn is given in 10-mL vials and 3-mL prefilled pens and is administered by injection once daily. The dosing of insulin glargine-yfgn should be based on the individual patient and should not be used during episodes of hypoglycemia or in patients with hypersensitivity to insulin glargine products. Further, like its reference product, insulin glargine-yfgn is not recommended for treating diabetic ketoacidosis.

Insulin glargine-yfgn may cause serious adverse effects (AEs), including hypoglycemia, severe allergic reactions, hypokalemia, and heart failure. The most common AEs associated with insulin glargine products other than hypoglycemia are fluid retention, pitting at the injection site, weight gain, and allergic reactions, such as injection site reactions, rash, redness, pain, and severe itching.¹

The approval of this biosimilar can provide patients with a safe and cost-effective insulin option. Biosimilars marketed in the United States typically have been released with initial list prices that are 15% to 35% lower than the list prices of the reference products.²

References

1. Analogue Insulin Diabetes. January 15, 2019. Accessed August 2, 2021. https://www.diabetes.co.uk/diabetes-prevention/index.html.

2. 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.