FDA Approves Insulin Glargine-aglr as Second Interchangeable Insulin Product

US Food and Drug Administration (FDA)

The US Food and Drug Administration (FDA) approved insulin glargine-aglr (Rezvoglar) from Eli Lilly, the second interchangeable biosimilar insulin product to insulin glargine (Lantus) for diabetes mellitus.

The biosimilar is a long-acting human insulin analog indicated to improve glycemic control in adults and pediatric patients with diabetes mellitus.

The agency previously approved insulin glargine-aglr as a biosimilar to insulin glargine on December 17, 2021. The biological product is highly similar to and has no clinically meaningful differences from an existing FDA-approved biologic, or the reference product.

An interchangeable biosimilar is a biosimilar product that has met additional requirements and can be substituted for the reference product at the pharmacy, but is dependent on state pharmacy laws. A company is required to specifically apply for interchangeability.

Thus, insulin glargine-aglr is the second approved biosimilar insulin, joining insulin glargine-yfgn (Semglee) which the FDA approved on July 28, 2021. If the agency approves a product as interchangeable, it may be substituted at the pharmacy level. As a result, patients may receive either insulin glargine-yfgn or insulin glargine-aglr at the pharmacy in place of insulin glargine.

The biosimilar will be available in 3 mL prefilled pens and is administered subcutaneously once daily. Dosing was indicated to be individualized based on a patient’s needs and should not be used during episodes of hypoglycemia or in patients allergic to insulin glargine products, or for the treatment of diabetic ketoacidosis.

Serious adverse effects related to insulin glargine-aglr included hypoglycemia, severe allergic reactions, hypokalemia, and heart failure. Meanwhile, the most common adverse effects associated with insulin glargine products included edema, lipodystrophy, weight gain, and allergic reactions, including injection site reactions, rash, redness, pain, and severe itching.

This approval was noted to further the agency’s commitment to supporting a competitive marketplace for insulin products. Greater availability of biosimilar and interchangeable insulin products may provide more treatment options for patients, with the potential to lower treatment costs and allow greater access to more individuals.