FDA Approves Insulin Biosimilar Rezvoglar

The biosimilar insulin glargine-aglr (Rezvoglar) is a long-acting human insulin analog for insulin glargine (Lantus), which was originally approved in December 2021. Rezvoglar has now received the U.S. Food and Drug Administration (FDA) interchangeability designation, allowing the product to be used in place of Lantus at the pharmacy level without requiring physician permission.

The FDA has approved Eli Lilly’s insulin glargine-aglr, sold under the brand name Rezvoglar, as the second-ever interchangeable biosimilar insulin product to Sanofi’s insulin glargine, sold under the brand name Lantus. Rezvoglar is a long-acting human insulin analog indicated to improve glycemic control in adults and pediatric patients with type 1 diabetes, and in adult patients with type 2 diabetes. It is not indicated for use in pediatric patients with type 2 diabetes

The FDA had previously approved Rezvoglar as a biosimilar to Lantus on December 17, 2021. The difference between the ‘biosimilar’ and ‘interchangeable biosimilar’ designation is that the latter meets additional requirements and can be substituted for a reference drug more easily. To qualify as interchangeable, Lilly had to prove there would be no risks or loss of efficacy for patients who switch from Lantus to Rezvoglar.

About Rezvoglar

Rezvoglar, available in 3-mL prefilled pens, is administered as a once-daily subcutaneous injection. Like Lantus, prescribing should be individualized based on the patient’s needs and should not be used during episodes of hypoglycemia or in patients allergic to any ingredients in insulin glargine products.

Also like Lantus, Rezvoglar is not recommended for treating diabetic ketoacidosis and may cause serious side effects, including hypoglycemia, severe allergic reactions, hypokalemia and heart failure. The most commonly reported side effects associated with any insulin glargine products are fluid retention (edema), pitting at the injection site (lipodystrophy), weight gain, and injection site reactions including rash, redness, pain and severe itching.

Because the FDA has approved Rezvoglar as an interchangeable biosimilar, it may be substituted by a pharmacist without consulting the physician if the state’s pharmacy laws permit. Rezvoglar is the second approved interchangeable biosimilar insulin in the U.S., joining Mylan Pharmaceuticals’ insulin glargine-yfgn (Semglee), which was the first approved interchangeable biosimilar to Lantus, that FDA approved on July 28, 2021. Patients may now receive either Rezvoglar or Semglee at the pharmacy in place of Lantus.

About Biosimilars

Biosimilar drugs are biological products that are highly similar to, and have no clinically meaningful differences from, an existing FDA-approved biologic (also called the reference product). An interchangeable biosimilar is a biosimilar that meets additional requirements and may be substituted for the reference product at the pharmacy level, if state pharmacy laws allow Biosimilars can be exchanged without physician permission if they have an interchangeable designation and can be expected to produce the same clinical result as the reference product in any given patient.

A Competitive Marketplace

The FDA recently announced a significant effort to streamline the approval of biosimilars, vowing to make the evaluation process simpler and more practical, and thereby less expensive. The approval of Rezvoglar supports the FDA’s commitment to supporting a competitive insulin marketplace. 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.

The process of gaining the FDA’s interchangeable biosimilar designation can be cumbersome and expensive for smaller pharmaceutical companies; the recently introduced Biosimilar Red Tape Elimination Act aims to reduce requirements for these studies so it is easier and cheaper for companies to establish interchangeability.

Key Takeaway

Interchangeable biosimilar insulin products represent a wider and potentially less expensive landscape of treatment options to patients with diabetes. The recent approval of Rezvoglar as another interchangeable biosimilar option for Lantus is a welcomed stride toward insulin affordability and accessibility, which may improve treatment adherence and outcomes for patients.

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