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."
Why did Sanofi go to the trouble, and the expense, to develop another version of insulin glargine?
Easy. As the Wall Street Journal points out, "Sanofi is counting on Toujeo to help offset sales it will lose when its top-selling drug, the insulin Lantus, loses U.S. patent protection, which is expected later this year. Encouraging doctors to switch patients to Toujeo and ensuring that the new insulin is paid for by health insurers will be [a] major challenge."
The reason it's a challenge: why should physicians switch their patients from Lantus (or other drugs) to the new and inevitably more expensive Toujeo? There simply isn't any reason, in my opinion. Nor do I see any reason for patients to ask their physicians to switch from Lantus to Toujeo. And it's likely that insurance companies will balk at adding Toujeo to their formularies when it's really just about the same as Lantus -- or they will tack on huge co-pays for the new insulin. So we have another new diabetes drug, but one that is nothing really exciting for people with diabetes or their physicians .
Disclaimer: I previously worked in pharmacovigilance (drug safety) for Sanofi (the manufacturer of Lantus).