The national news has been awash with announcements by the three major branded insulin manufacturers of price cuts of up to 80%. Sanofi was the last to announce its 78% insulin price cut. Lilly announced 70% reductions, and Novo Nordisk dropped its insulin prices by 75%. Importantly, the announcements were also accompanied by a $35 monthly cap on patient out-of-pocket costs.
This was in response to increasing pressures on manufacturers, including biosimilar competition, legislative pressure, and public outcry regarding patient cost sharing. This is welcome news overall, resulting in reasonable caps in monthly prices that patients pay. This may be less welcome by companies working on biosimilar insulin candidates. That includes Lannett and Amphastar, the former completed its clinical trials in November 2022, and was anticipated to file for approval this year. Biocon, which bought Viatris’ portfolio, had inherited a biosimilar insulin product, whose 351(k) application was originally rejected.
Previously, health systems had reacted to high insulin prices and price increases by supporting the biosimilar (and generic) development of several medications through the nonprofit CivicaRx. CivicaRx had also announced that it will introduce its first biosimilar insulins by next year (assuming approval by FDA). On March 18, CivicaRx stated that California signed a contract with them to manufacturer insulins for the state and keep the price down to $30 per 10-mL vial.
All of this raises the question of whether it makes sense for for-profit biosimilar makers to continue development work on their insulin candidates. Certainly, for some manufacturers, development work is far along, and the greatest share of R&D costs have already been incurred. However, the potential revenues associated with these products seem to be dropping, and quickly. Requests for comment to Lannett and Amphastar went unanswered. Lannett, a generic drug maker, may be satisfied with adding biosimilar insulin, at generic-drug prices, to its product portfolio.
Will other organizations continue with their plans? Do the actions of the branded manufacturers obviate even the need for CivicaRx’s efforts? What may become of the 505(b)2 agents Basaglar® or Admelog®, or of Biocon’s Semglee® biosimilar? Is this a prelude to some approved biosimilar or branded products exiting the market? These are all valid questions. Make no mistake, the lower prices and caps on patient copays are great news, but they are the sort of outcomes that we had hoped would result directly from biosimilar competition. That could have sustained the biosimilar insulin market over an extended period. We’re not so sure today.
