Second Interchangeable Biosimilar for Insulin Glargine Approved by FDA

The FDA has announced the approval of insulin glargine-aglr (Rezvoglar) as the second interchangeable biosimilar to insulin glargine (Lantus). Rezvoglar is a long-acting human insulin analog that is indicated to improve glycemic control in both adults and children with diabetes.

Rezvoglar was approved as a biosimilar on December 17, 2021. Following the current approval, it joins insulin glargine-yfgn (Semglee) as the only other approved insulin interchangeable biosimilar. Products that are approved as interchangeable biosimilars may be substituted at the pharmacy level on a state-by-state basis. Patients who are prescribed insulin glargine may receive either of the 2 approved interchangeable biosimilars instead.

Insulin glargine-aglr is available in 3 mL prefilled pens and is administered subcutaneously once daily. Dosing should be individualized based on patient needs, and should not be used during hypoglycemic episodes.

“This approval furthers FDA’s longstanding commitment to support a competitive marketplace for insulin products,” the CDER noted. “The availability of biosimilar and interchangeable insulin products can provide more treatment options to patients, potentially lowering treatment costs and enabling greater access.”

Reference

1. FDA approves second interchangeable insulin product, rezvoglar (insulin glargine-aglr). FDA Center for Drug Evaluation and Research. Accessed November 17, 2022.