The manufacturer of a very popular insulin product, Lantus (insulin glargine), has a problem.The drug, which had 5.72 billion euros ($7.7 billion) in sales last year, loses patent protection soon. Typically, when a drug goes off-patent, profits plummet, as competitors flood the market with less-expensive competitors. There's already a "me-too" (second to market) version of insulin glargine that's approved in the US, but sales of this competitor are hung up due to litigation from Lantus's manufacturer, Sanofi.
So what does Big Pharma due when they are threatened with losing their profits? Well, as mentioned in the previous paragraph, they sue anyone who might compete. And they develop a me-too of their own. The me-too version of Lantus has been given the name Toujeo, which will be available for sale sometime later this year.
In this case, Sanofi decided to do the following:
Simply change the concentration of insulin in the insulin glargine vials from 100 units of activity per milliliter (AKA U-100) to 300 (U-300).
Do the necessary studies to show the FDA that Toujeo is the same as Lantus. Sure enough, studies using Toujeo and comparing it to Lantus showed it was the same as Lantus: according to the company's press release, "All studies of the EDITION program successfully met the primary study endpoints by demonstrating similar blood sugar control with Toujeo as compared to Lantus."