The Food and Drug Administration (FDA) has approved Rezvoglar (insulin glargine-aglr) as the second interchangeable biosimilar insulin product to Lantus (insulin glargine).
Rezvoglar is a long-acting human insulin analog indicated to improve glycemic control in adults and pediatric patients with diabetes mellitus. According to the FDA, an interchangeable product is a biological agent that is approved based on data demonstrating that it is highly similar to an approved reference product and that there are no clinically meaningful differences between the products. The interchangeable product can be expected to produce the same clinical result as the reference product in any given patient.
The FDA previously approved Rezvoglar as a biosimilar in December 2021 based on data demonstrating that there were no clinically meaningful differences between the biosimilar and the reference product. As an interchangeable biosimilar, Rezvoglar may now be substituted for Lantus at the pharmacy level without the need for an intervention from the prescriber.
Rezvoglar is supplied as a solution containing 100 Units/mL in 3mL KwikPen single-use prefilled pens. The Rezvoglar KwikPen prefilled pen dials in 1 unit increments.
Rezvoglar. Package insert. Eli Lilly and Company; 2021. Accessed November 17, 2021. https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761215s000Orig2s000.lbl.pdf.