- Sanofi's patent on Lantus (insulin glargine) expired last month, making room for Lilly's Abasglar in the E.U. Lilly and Boehringer Ingelheim are co-marketing the new biosimilar version of Lantus.
- Lantus, used for long-term glycemic control, is Sanofi's biggest-selling drug and had $7.05 billion in sales last year.
- Although Lantus's biosimilar (which will be called Basaglar in the U.S.) is not marketed yet in the U.S., the FDA granted it tentative approval in August 2014.
When Sanofi's Lantus was approved in April 2000, it became the first FDA approved long-acting (basal) recombinant human insulin analog with a once-daily administration and a 24-hour glucose-lowering effect. For the past 15 years, it has been the go-to basal insulin for many endocrinologists and primary care physicians who treat patients with diabetes. Sales have continued to climb, with an increase of 12% between 2013 and 2014.
While Lilly/BI's biosimilar version of Lantus has the go-ahead in Europe to hit the market, its introduction in the U.S. is subject to delay because of a patent-infringement lawsuit. If the courts don't determine that Lilly's position is legally correct, then Lilly and BI won't be able to introduce Basaglar in the U.S. until 2016.
One wildcard remains pricing. It's still not clear how Abasglar will be priced. Once that becomes clear, it will send a signal to the larger medical community about how pricing decisions might be made for other biosimilar entrants.