A recent study finds that the approval of a biosimilar was associated with a change in the trajectory of net prices.
After approval of Basaglar, a biosimilar of Lantus (insulin glargine injection), there was a significant downward trend in pricing of Lantus, with net prices decreasing on average $0.67 per quarter relative to the preapproval trend. This is the finding of a study published recently in JAMA Internal Medicine.
The reference biologic, Lantus, has been sold by Sanofi since 2000. The FDA approved Basaglar, a biosimilar sold by Eli Lilly and Boehringer Ingelheim, in December 2015 but because of patent litigation with Sanofi, it did not become available in the United States until December 2016.
Insulin glargine is a long-acting, manmade version of human insulin for patients with diabetes.
In this study, investigators studied shifts in total U.S. sales and net prices for all three insulin glargine products from the first quarter of 2010 through second quarter of 2020. They found that from the first quarter of 2010 through the third quarter of 2014, list prices for Lantus—the only insulin glargine on the market at the time—rose from $9.23 to $22.21, or 4.9% quarterly. Net prices were lower than list prices (at $6.94 and $12.79, respectively) and rose slower, 3.8% quarterly.
Between 2015 and 2020, list prices remained steady, but net prices of Lantus and the weighted average net price of insulin glargine declined (at rates of 5.2% and 3.4% per quarter, respectively.
Lantus maintained the highest net sales throughout the period, although by 2020, Basaglar accounted for 39% to 41% of all net sales compared with 45% to 46% for Lantus.
Between the initial approval and launch of Basaglar, Sanofi launched Toujeo, an insulin glargine with a higher concentration than Lantus that would not directly compete with Basaglar. Investigators speculated the introduction of Toujeo was a possible strategic move to maintain market share. But Toujeo, which began to be sold by Sanofi at the end of Lantus’ exclusivity period, never gained greater than 15% market share, and its price converged with Lantus and Basaglar after the biosimilar entered the market.
Since the time of the study period, an additional insulin glargine has become available. Mylan and Biocon Biologics launched Semglee in August 2020 with a list price that matched Lantus’ 2010 pricing.
Additionally, a just-released study by the National Institutes of Health has found that liraglutide, a glucagon-like peptide-1 receptor agonist (GLP-1 RA), or insulin, are the best options for maintaining A1C.