Rezvoglar Is the Second FDA-Approved Biosimilar Insulin Product

The Food and Drug Administration (FDA) approved Rezvoglar (insulin glargine-aglr), the second interchangeable biosimilar insulin product in the United States. Like Semglee, which was approved last year, Rezvoglar can serve as an affordable substitute for the more costly Lantus.

Rezvoglar is a long-acting insulin designed to manage blood sugar levels in adults and young patients with type 1 diabetes and in adults with type 2 diabetes.

"This approval furthers the FDA’s longstanding commitment to support a competitive marketplace for insulin products,” the FDA wrote in a statement. “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 FDA said patients with diabetes can receive either Semglee or Rezvoglar at the pharmacy as an alternative to Lantus.

According to Michael D. Goldberg, MD, an associate professor of clinical medicine at New York Medical College, Rezvoglar was approved as a biosimilar to Lantus last year and then designated as interchangeable with Lantus in November.

When a drug is categorized as “biosimilar” it indicates that the drug is highly similar to and has no meaningful difference in clinical effect or safety from an existing FDA-approved reference drug.

When a drug is classified as “interchangeable,” the drug can be substituted for a reference drug at the pharmacy level, without requiring permission from the prescribing provider, Goldberg said. However, that policy could vary depending on a state’s pharmacy laws. This FDA approval may also allow patients to have easier access to generic insulin if the prescribed drug is not available.

“In other words, if a provider prescribes Lantus for their patient, the patient’s pharmacy may choose to dispense Semglee or Rezvoglar instead, without any need to consult the provider, if this practice is allowed in that particular state,” Goldberg said.

What Does This FDA Approval Mean for the Cost of Insulin? 

According to the FDA, this approval is significant because it expands patient access to biosimilar and interchangeable insulin products. This decision can potentially lower the cost of diabetes treatment, according to Eliud Sifonte, MD, an endocrinologist at NYU Langone Health.

“In 2009, Congress passed the BPCI Act to create a shortened pathway for approval of products that are biosimilar to other FDA-approved medications,” Sifonte said. “The idea behind this is to create competition in the hopes of lowering the costs of medications.” 

While the exact cost for Rezvoglar has not been announced yet, Goldberg said biosimilar insulins tend to be less expensive than their reference drugs, like how generic medications are usually cheaper than their brand-name equivalent.

“It is important to keep in mind that actual out-of-pocket costs for any medication depend on other factors as well, such as insurance formulary coverage, deductibles, and copayments,” Goldberg added.

How Can You Get Rezvoglar? 

Rezvoglar is available as a 3 ml prefilled pen and is injected once daily, underneath the skin, according to the FDA. However, the drug’s dosing and administration should be individualized and based on the patient’s metabolic needs, blood sugar monitoring, glycemic control, type of diabetes, and prior insulin use.

Your access to Rezvoglar depends on your health insurance coverage and prescription, but you can talk to your healthcare provider or pharmacist about different insulin options.

“Some states permit the pharmacist to make the change automatically if a biosimilar is available and cheaper,” Sifonte said. “Other states require the prescribing physician’s approval.”