On March 4, 2019, Eli Lilly announced that they will begin selling a lower-priced version of Humalog® (isulin lispro injection 100 units/mL) in the United States with a list price 50% lower than the current Humalog® list price. The lower-priced version will be called Insulin Lispro and will be provided in both vials and pens. Insulin Lispro will be made available as an authorized generic through a Lilly subsidiary, ImClone Systems, and will continue to be available through insurance plans. Lilly has not provided a projected launch date but plans to make Lispro Insulin “available in pharmacies as quickly as possible.”
The high price of insulin, and Humalog® in particular, is an issue that was addressed in a letter to FDA Commissioner Scott Gottlieb from U.S. Senators Richard Durbin, Kevin Cramer, Tina Smith and Bill Cassidy on March 1, 2019. The letter cites the more than 10-fold price increase in Humalog® since 1996. In addition to urging the FDA to expedite approval of lower-cost biosimilar insulin products, the senators expressed concern that FDA’s transition of follow-on insulin from New Drug Applications to Biologics License Applications could delay introduction of low-cost insulin products into the market. The senators requested a response from FDA by March 15, 2019 providing “an explanation on (1) the steps FDA is taking to expedite the approval of insulin follow-on applications prior to the March 23, 2020 deadline, (2) how many applications are currently pending, and (3) whether FDA anticipates approving any insulin follow-on applications prior to the March 23, 2020 deadline.”