FDA approves second insulin glargine biosimilar
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The FDA approved insulin glargine-aglr, a second biosimilar to Sanofi’s insulin glargine, to improve glycemic response in children and adults with type 1 diabetes and adults with type 2 diabetes.
Insulin glargine-aglr (Rezvoglar, Eli Lilly) is a long-acting insulin analog available as a 3 mL prefilled KwikPen, to be administered once daily, according to the package insert.
A biosimilar is a biological product that is highly similar to, and has no clinically meaningful differences from, a biological product already approved by the FDA. As a biosimilar, insulin glargine-aglr can be used in place of insulin glargine (Lantus, Sanofi). However, insulin glargine-aglr is not an interchangeable biosimilar product, which may be substituted for the reference product without the intervention of the prescriber.
As Healio previously reported, the FDA in July approved the first interchangeable biosimilar insulin product, insulin glargine-yfgn (Semglee, Viatris), to improve glycemic control for children and adults with diabetes. Insulin glargine-yfgn was approved as a drug product under the 505(b)(2) new drug application pathway and is now deemed a biologic under section 351(a), in accordance with the Biologics Price Competition and Innovation Act.
In a press release announcing the first biosimilar approval, the FDA noted that biosimilars marketed in the U.S. typically have launched with initial list prices 15% to 35% lower than comparative list prices of the reference products; however, experts have debated whether biosimilar insulin products will substantially lower cost to patients.
In October, Express Scripts announced it will prefer insulin glargine-yfgn on its largest formulary.
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Rezvoglar package insert
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