FDA approves second interchangeable insulin glargine biosimilar for patients with diabetes
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The FDA approved the second interchangeable insulin glargine biosimilar, Rezvoglar, to improve glycemic control in adults and pediatric patients with diabetes, according to a drug information update from the agency.
Biosimilars are biological products that are similar to biological products already FDA approved without any clinically meaningful differences.
As Healio previously reported, insulin glargine-aglr (Rezvoglar, Eli Lilly) was approved by the FDA as a biosimilar to insulin glargine (Lantus, Sanofi) in December 2021. Rezvoglar is the second biosimilar insulin to be deemed interchangeable in the U.S. following approval of insulin glargine-yfgn (Semglee, Mylan) as an interchangeable biosimilar insulin in July 2021. This FDA approval means patients can receive Semglee or Rezvoglar at their pharmacy in place of insulin glargine.
Currently, Rezvoglar is available in 3 mL prefilled pens and is administered once daily subcutaneously. This drug’s dosing should be individualized based on each patient’s needs and should not be used during hypoglycemic episodes or in patients who are allergic to insulin glargine products.
Rezvoglar is not recommended for use in treating diabetic ketoacidosis.
According to the press release, this FDA approval allows for more availability of biosimilar and interchangeable insulin products, which can provide more treatment options to patients and may also lower treatment costs and expand treatment access.
Reference:
- FDA’s Center for Drug Evaluation and Research. FDA approves second interchangeable insulin product, Rezvoglar (insulin glargine-aglr).
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