The announcement on March 4 that Civica, the private-public partnership among 25 health systems, plans, and foundations, will be producing low-cost insulin in the near future may shake biosimilar insulin competition to its foundations.
Skyrocketing insulin prices caught the eye of health providers, advocacy groups, and Congress. This prompted the two main insulin makers, Eli Lilly and Novo Nordisk, to make available “authorized generic” versions of their insulin aspart and lispro in 2019 and 2020, respectively (with around a 50% price break). However, GoodRx reports that their brands Humalog® and Novolog® actually saw price increases over the past 2 years. The introduction in 2016 of Basaglar®, a 505(b) follow-on insulin glargine product, finally introduced desperately needed competition to this specific drug category. Prices began to level off and then decline. The FDA approval of Semglee®, first as a follow-on product in 2020 and then as an interchangeable biosimilar in 2021, further deflected the pricing trajectory downward. In July 2021, partners Biocon and Viatris introduced Semglee at a 65% discount to the originator agent Lantus® ($147.98 for a 5-pen package; GoodRx indicates the average price is more like $190). In comparison, Lantus’ average price is $513 per carton of 5 pens. Lilly has also received approval for its own biosimilar glargine, Rezvoglar®, but pricing on this agent is not yet known.
Civica’s announcement, essentially that it was entering the biosimilar arena, will garner a great deal of attention. The target price it will set is $30 per vial and no more than $55 for a box of five pens. That would be 70% less than any other glargine product—reference, follow-on, or biosimilar (see chart). Of course, these retail prices do not reflect the costs to payers and PBMs; insulins are subject to considerable discounts and rebates.
Civica was formed as a nonprofit generic pharmaceutical company in 2018, expressly to address chronic drug shortages in hospitals and their high prices. The organization is building a manufacturing plant in Virginia to produce the medications. Civica already produces approximately 60 sterile injectable generic medications, supplying more than 1,500 hospitals. This will be Civica’s first foray into insulins, and biosimilars.
Although the company could not provide a target date for commencing their clinical studies, including phase 3 interchangeability trials, spokesperson Debbi Ford stated in an Email, “Civica’s team has members with vast experience with biologics, and we plan to work closely with the FDA on the design of our studies.”
The big question here is how biosimilar manufacturers will compete with a nonprofit. Civica has not yet produced a generic product for distribution to community pharmacies or via mail order. Although this represents a departure for them, it does not bode well for other manufacturers trying to commercialize their own insulin biosimilars (e.g., Lannett, Viatris/Biocon, or others who have not publicly disclosed their plans). Civica’s timing may not pan out, but their successful entry may have the same result as a “race-to-the-bottom” in pricing, which would negatively alter the expectations of existing and future insulin suppliers.
(Revised March 7th)