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.”