Lilly Plans to Launch Insulin Biosimilar at 78% Discount to Lantus

In its statement announcing that it will significantly cut its insulin products, Eli Lilly and Company shared that it will launch its interchangeable insulin glargine biosimilar, Rezvoglar, at a 78% discount to the originator (Lantus).

Rezvolgar (insuling glargine-aglr) was approved as the fourth biosimilar to receive an interchangeability designation in November 2022. It was originally approved by the FDA in December 2021 and was the second insulin biosimilar to receive the interchangeability label, following the approval of Semglee (insulin glargine-yfgn) in July 2021.

Lilly said the biosimilar will be available to patients for $92 for a 5-pack of KwikPens, the companies auto-injector device, on April 1, 2023. Besides Rezvoglar, Lilly is the manufacturer of Humulin (recombinant human insulin) and Humalog (reference insulin lispro) as well as an unbranded insulin lispro product.

The price for the unbranded insulin lispro (100 u/mL) will now be $25 per vial, effective May 1, 2023. When the price drop goes into effect, it will be the lowest list-priced mealtime insulin available and at a lower pricepoint than Humalog was in 1999. Effective in the fourth quarter of 2023, the prices of Humulin (100 u/mL) and Humalog (100 u/mL) will be cut by 70%. Humulin is the most commonly prescribed Lilly insulin.

In addition to reducing the price of its insulin products, Lilly will automatically cap out-of-pocket costs for $35 at participating retail pharmacies for people with commercial insurance using any Lilly insulin.

The news comes after the Inflation Reduction Act (IRA)’s $35 out-of-pocket insulin cap for Medicare Part D beneficiaries went into effect. A report from HHS claimed that if the Part D cap had gone into effect in 2020 instead of 2022, beneficiaries could have saved a total of $734 million, or about $500 per member per year.

Additionally, prior to the passage of the IRA through Congress, a provision to extend the $35 out-of-pocket cap to the commercial sector was removed from the budget reconciliation bill after Republicans raised a point of order to nix the measure, forcing a vote. Although the Democrats has a majority vote, it did not meet the 60-vote threshold needed to keep the provision in the bill.

“While the current health care system provides access to insulin for most people with diabetes, it still does not provide affordable insulin for everyone and that needs to change…. The aggressive price cuts we're announcing today should make a real difference for Americans with diabetes. Because these price cuts will take time for the insurance and pharmacy system to implement, we are taking the additional step to immediately cap out-of-pocket costs for patients who use Lilly insulin and are not covered by the recent Medicare Part D cap,” commented David A Ricks, MBA, Lilly’s chair and CEO.

People who do not have insurance will also be able to go to InsulinAffordability.com to download the Lilly Insulin Value Program savings card, which will allow uninsured patient to receive Lilly insulin products for $35 per month.

Ricks explained that although 70% of Americans don’t use Lilly insulin products, the company is still calling on policymakers, employers, and others to follow in Lilly’s footsteps to lower prices and increase accessibility to insulins.

“For the past century, Lilly has focused on inventing new and improved insulins and other medicines that address the impact of diabetes and improve patient outcomes. Our work to discover new and better treatments is far from over. We won't stop until all people with diabetes are in control of their disease and can get the insulin they need," he said.

High insulin costs have resulted in many patients with diabetes rationing their insulin or stopping treatment, which can lead to devasting health consequences, including nerve and vision damage, amputations, and kidney and cardiovascular disease.

Stacie Dusetzina, PhD, professor of health policy at Vanderbilt University and editorial board member at The American Journal of Managed Care^®, a sister publication of The Center for Biosimilars^®, told the Associated Press that these changes will likely not affect Lilly much from a financial standpoint because the insulins are older, with some already facing competition.

When Rezvoglar launches, it will compete against Basaglar and Semglee, and Humalog is already competing with Lyumjev. Although Semglee is an official biosimilar, Basaglar and Lyumjev are considered follow-on biologics because they were approved by the FDA before a biosimilars approval pathway was established. As a result, they are not formally classified as biosimilars by the FDA but may be considered biosimilars by international regulatory agencies.