The FDA has granted Eli Lilly’s long-acting insulin glargine biosimilar, Rezvoglar, an interchangeability designation, making it the second interchangeable insulin biosimilar in the United States.
The FDA approved for Rezvoglar (insulin glargine-aglr), a biosimilar for Lantus (insulin glargine) that was originally approved in December 2021, for an interchangeability designation, allowing the product to be exchanged for the reference product at the pharmacy level without requiring physician permission.
“This approval furthers the 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,” the FDA wrote in a statement.
The biosimilar, developed by Eli Lilly, is a long-acting human insulin analog that can help improve glycemic control in adult and pediatric patients with type 2 diabetes. It is the second insulin biosimilar to receive an interchangeability designation, following Semglee (insulin glargine-yfgn), which was granted interchangeability in July 2021.
Interchangeability designations allow for patients to have easier access to biosimilars by reducing the time it takes for patients to receive their prescription if the drug that is being prescribed is not available, similar to how generic drugs are substituted for branded drugs.
When Rezvoglar launches, it will be offered in 3-mL prefilled pens that can be administered subcutaneously once daily. Dosing of the biosimilar should be individualized based on patient needs and should not be utilized during hypoglycemic episodes or if patients are allergic to insulin glargine products. It is not recommended for the treatment of diabetic ketoacidosis.
Will the Interchangeability Designation Matter?
Uptake for the unlabeled version of Viatris and Biocon’s Semglee only achieved 1% of the commercial market and 7% of the Medicaid market for the first 10 months prior to the launch of Semglee with the interchangeability label, according to a report from IQVIA.
The market share in the commercial space jumped to 15% after interchangeable Semglee was made available. The unlabeled version continues to perform better in the Medicaid space, and the interchangeable version performs better in the commercial market.
Authors of the report claimed that an interchangeable designation only played a small part in increased adoption and argued that payer formulary lists were the main driver of biosimilar insulin adoption. However, when payers implement formulary restrictions, they typically apply to new patients so as not to disrupt the treatment of those who are already stable on their current therapies.
Whether interchangeability can function properly depends on payer policies and state laws. Although interchangeability allows for an easier substitution process for biosimilars, it does not get around prior authorization requirements placed by payers. Additionally, different states have different notification requirements for patients and providers on whether an interchangeable biosimilar is being dispensed in place of another product, and 4 states have banned the practice. Time will tell if more interchangeable insulins will help bring down the overall price of insulin products and increase adoption of insulin biosimilars.
Off the Heels of the Twitter Debacle
The news comes after Lilly experienced a sudden drop in the company’s stock after a Twitter user impersonated the company using the social media platform’s short-lived paid verification feature, claiming that Lilly was going to make insulin products free. The stunt led many Twitter users to criticize Lilly and other companies.
During his remarks defending Lilly’s pricing, David Ricks, MBA, the company’s CEO, said that people should keep in mind that newer long-acting insulin products are different from the original version of insulin from 100 years ago but agreed that Lilly needs to act better regarding insulin pricing, saying, “It probably highlights that we have more work to do to bring down the cost of insulin for more people.”