Eli Lilly Launching Lower-Priced Authorized Generic of Its Insulin Lispro

Eli Lilly and Company said Monday it is introducing a lower-priced authorized generic of its insulin lispro injection (Humalog) in the United States. The generic will have a list price 50% lower than the current Humalog list price.

The price of insulin has been top-of-mind for many lawmakers from both sides of the aisle, starting with a Senate Finance Committee hearing in January, as well as a probe opened last month into insulin costs.

"We've engaged in discussions about the price of insulin with many different stakeholders in America's health care system: people living with diabetes, caregivers, advocacy groups, health care professionals, payers, wholesalers, lawmakers, and leading health care scholars," David A. Ricks, Lilly's chairman and chief executive officer, said in a statement. "Solutions that lower the cost of insulin at the pharmacy have been introduced in recent months, but more people need help. We're eager to bring forward a low-priced rapid-acting insulin."

Ricks referenced some of the discussion happening in Washington around drug prices, including a proposal from HHS to block rebates and discounts given to pharmacy benefit managers (PBMs), Part D plans, and Medicaid managed care organizations, by saying “a lower-priced insulin can serve as a bridge that addresses gaps in the system until a more sustainable model is achieved."

The company said the lower-priced version will be available in both vial and pen options. The list price of a single vial will be $137.35. The list price of a 5-pack of KwikPens will be $265.20. That is somewhat higher than Sanofi’s short-acting follow-on insulin lispro product, Admelog, which references Lilly’s Humalog. Under Sanofi’s “Insulins VALyou Savings Program,” nonfederally insured patients are eligible for a savings card that will allow them to purchase the product for a total out-of-pocket cost of $99 for a 10-mL vial or $149 for a box of five 3-mL pens for a period of 12 months.

Lilly said it is working with supply chain partners to make the vials and pens available in pharmacies quickly. It will be made available as an authorized generic through a Lilly subsidiary, ImClone Systems.

One advocacy group for lower drug prices said Lilly's action was insuffient. In a statement, Ben Wakana, executive director of Patients For Affordable Drugs, said, “Clearly, the insulin cartel is feeling pressure after years of price gouging a lifesaving drug. But charging nearly $140 for a vial of insulin—a drug that was invented almost a century ago—is still too high." He said the country needs "systemic changes to fix the broken insulin market and finally solve America’s insulin affordability crisis.”

The launch of the authorized generic is not surprising, as Lilly hinted as much in comments it made last month regarding the FDA’s proposed approach to the transition of insulins and other products that have historically been regulated as drugs and follow-ons to regulation as biologics and biosimilars.

In its comments, the company voiced its support of the FDA’s proposed approach to the transition of products that are currently addressed under the Federal Food, Drug, and Cosmetic Act to regulation under the Public Health Service Act in 2020. However, the company called on the FDA to clarify whether drug product developers can introduce “second versions” of their innovator biologics, calling these potential products “branded biosimilars” or “authorized biologics.”

Authorized generic drugs are the same products as brand-name small-molecules with respect to active ingredients, conditions of use, dosage, strength, and route of administration, but may have minor differences (such as different inactive ingredients or different colors or markings) and are not sold under the branded drug’s name.

Examples of such authorized generics are versions of Gilead’s hepatitis C treatments Harvoni and Epclusa that carry list prices of approximately one-third of the originator drugs.