Insulin Glargine Update: Price Savings with Basaglar?

According to a 2015 study by RAND, insulin glargine biosimilars/follow-on agents were supposed to contribute 15% to total cost savings in overall biologic expenditures. This would be substantial, considering the size of the insulin marketplace, and their potential to slow increasing market shares from next-generation long-acting insulins.

But the savings may not be that quick to accrue. When Lilly introduces its version of insulin glargine (Basaglar) to the long-acting insulin market next month, what will the savings be? As a reminder, this product is not a biosimilar, according to its regulatory approval pathway, but a follow-on biologic, which means that it required more clinical trial data.

But the savings may not be that quick to accrue. When Lilly introduces its version of insulin glargine (Basaglar) to the long-acting insulin market next month, what will the savings be? As a reminder, this product is not a biosimilar, according to its regulatory approval pathway, but a follow-on biologic, which means that it required more clinical trial data. For example, Lilly conducted 2 Phase 3 studies (ELEMENT-1 and ELEMENT-2) with patients with types 1 and 2 diabetes mellitus, respectively) who had been treated prior to enrolling in the investigation. Furthermore, design and development costs of the pen-delivery device must be considered.

On this basis, one should not expect more than 15% discounts off of wholesale acquisition cost. This does not consider possible rebates and individual contracts made with CVS Health and OptumRx to prefer Basaglar and exclude Lantus^® from coverage. However, it does seem reasonable that additional versions of insulin glargine will need to enter the marketplace before general discounts are commonly seen.

When might this occur? The next drug up for approval is a result of the Merck—Samsung Bioepis collaboration. On August 5, 2016, the FDA accepted their application for 351(a) approval of MK-1293. They also filed for biosimilar approval in Europe earlier this year, with the hope of receiving positive news from the EMA before the end of the year.

On November 3, 2016, Biocon and Mylan submitted its application to the European Medicines Agency (EMA) for a biosimilar to insulin glargine. Lilly had submitted its drug as a biosimilar as well to the EMA, and as a result, it is already available in the EU. There is no word as of yet when Biocon/Mylan’s 351(a) application will be submitted to the FDA. Its 500-patient phase 3 study of this product versus Lantus^® in patients with type 1 diabetes was completed in June 2016. Its 600-patient phase 3 investigation in patients with type 2 diabetes was estimated to be completed in June as well. An open-label extension study of the agent is underway and will be finished in March 2017. This seems to support—assuming positive results, of course—a regulatory submission no earlier than Q4 2017.

Therefore, it may be late 2018 before 3 follow-on insulin glargine products are actively competing with Lantus^® and its next-generation insulin glargine brand. By that time, discounts and rebates may mean savings of 30% or more, as the category becomes saturated, to nearly commodity levels.