According to a study published in JAMA Internal Medicine this month, the approval and launch of the follow-on insulin glargine product Basaglar turned the tide on rising costs for this long-acting insulin.
Approved as a 505(b)2 insulin in August 2014 (prior to the category being transitioned to the 351[k] biosimilar regulatory pathway), Basaglar was the first competitive launch to challenge Lantus®. From 2010 to 2014, according to investigators from Johns Hopkins’ Bloomberg School of Public Health, the wholesale acquisition cost (WAC) of Lantus was rising on average 4.9% per quarter. During that period, the WAC jumped from $9.23 to $22.21 per 100 IU. Estimated net prices were supplied by the SSR Health Drug Database, and these also rose, but at a 3.8% quarterly clip, to $12.79 in 2014.
Basaglar was not launched by Eli Lilly and Boehringer Ingelheim until late 2016, and although Lantus’ WAC remained steady at that time, its estimated net cost dropped by 5.2% per quarter. Basaglar captured as much as 41% of the net glargine sales by Q1 2020, compared with 46% for Sanofi’s Lantus. The rest was attributed to Sanofi’s high-concentration follow-on brand, Toujeo®, which was introduced in 2017, most likely as a tool to offset eroding Lantus’ sales.
The next entrant into the glargine competition, Semglee® was approved later in 2020, and so did not register any marketshare at this point. However, Semglee was initially approved later in 2020 as another 505(b)2 agent, and did not register any marketshare at this point.
This week, the Center for Biosimilars reported that Viatris and Biocon’s product, which in July received approval as both a biosimilar and interchangeable glargine, grabbed preferred status on Express Scripts’ primary national formulary. This, and other potential PBM contracts, may have significant effects on both the marketshare profile of the category and on net pricing over upcoming quarters. In this article, Express Scripts asserted that it will save $22 million a year on the switch.
The researchers noted that this research did not consider the possible effect of other long-acting insulins (detemir or degludec) on WAC or net prices in the category. However, it is clear that increasing competition from Semglee and perhaps new follow-on and biosimilar launches will assure the continuing downward slide of Lantus’ and Toujeo’s net costs, as payers reevaluate their formulary preferences for 2022.