Update on Insulin Prices and Pipeline Products

In March 2023, the three major insulin manufacturers (Eli Lilly, Novo Nordisk, and Sanofi) reduced the list prices of several brand insulins, effective in 4Q 2023 (Lilly), and on January 1, 2024 (Novo and Sanofi). These changes may impact the development and commercial success of insulin biosimilars.

Insulin is a highly visible and utilized category in which affordability is a top concern. The insulin class has historically been heavily influenced by rebates. However, the recent announcements may significantly change the role of rebates in management of the class, as utilization may shift in favor of the insulins with price cuts.

In the short-acting insulin space, Biocon’s MYL-1601D, a biosimilar to Novo’s NovoLog, is the closest to FDA approval. It received two complete response letters (CRLs) in 2022 and may receive approval this year if the company resolves the issues noted in the CRLs.

There are currently two approved biosimilars to Sanofi’s Lantus: Biocon’s branded and unbranded Semglee and Lilly’s Rezvoglar. Unless there are additional price announcements, Lantus and Rezvoglar will have the lowest list prices once the price reductions are effective. Future success in the long-acting insulin space may come from novel once-weekly insulins currently in development.