Burger line Burger line Burger line
Logo Logo Logo
Burger line Burger line Burger line
Sign in
Sign in

FDA Approves Second Interchangeable Insulin Product, Rezvoglar (insulin glargine-aglr)

FDA Approves Second Interchangeable Insulin Product, Rezvoglar (insulin glargine-aglr)

The U.S. Food and Drug Administration approves the second interchangeable biosimilar insulin product to Lantus (insulin glargine), Eli Lilly’s Rezvoglar (insulin glargine-aglr).  

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

FDA previously approved Rezvoglar as a biosimilar to Lantus on December 17, 2021. A biosimilar is a biological product (biologic) that is highly similar to and has no clinically meaningful differences from an existing FDA-approved biologic, called a reference product. 

An interchangeable biosimilar is a biosimilar that meets additional requirements and may be substituted for the reference product at the pharmacy, depending on state pharmacy laws, similar to how generic drugs are substituted. A company has to specifically apply for interchangeability.  

Rezvoglar is the second approved interchangeable biosimilar insulin in the U.S. Rezvoglar joins Semglee (insulin glargine-yfgn), the first approved interchangeable biosimilar to Lantus, that FDA approved on July 28, 2021. If FDA has approved a product as interchangeable, it may be substituted at the pharmacy level, if the state pharmacy law permits. Therefore, patients may receive either Semglee (insulin glargine-yfgn) or Rezvoglar (insulin glargine-aglr) at the pharmacy in place of Lantus (insulin glargine).  

Rezvoglar, available in 3 mL prefilled pens, is administered subcutaneously once daily. Dosing of Rezvoglar, like Lantus, should be individualized based on the patient’s needs and should not be used during episodes of hypoglycemia (low blood sugar) or in patients allergic to insulin glargine products. Also, like Lantus, Rezvoglar is not recommended for treating diabetic ketoacidosis. Rezvoglar may cause serious side effects, including hypoglycemia (low blood sugar), severe allergic reactions, hypokalemia (low potassium in your blood) and heart failure. The most common side effects associated with insulin glargine products other than hypoglycemia include edema (fluid retention), lipodystrophy (pitting at the injection site), weight gain and allergic reactions, such as injection site reactions, rash, redness, pain and severe itching. 

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

November 21, 2022


0
Cart Subtotal:
Go to cart
You will be able to Pay Online or Request a Quote