Sanofi brings lawsuit against Lilly for insulin ‘biosimilar’

With the leading insulin’s patent set to expire in February 2015, two leading manufacturers have put forward new drug applications for insulin glargines and, now, Sanofi has brought a lawsuit against Lilly for its pursuit.

In the lawsuit, Sanofi, which manufactures Lantus (insulin glargine), cites seven patents held from 2009 through 2014, which secure the company’s hold on Lantus, the global leader in insulin.

The company states that Lilly submitted a new drug application for a similar product, LY2963016 or Abasria, and that application is based on studies comparing the Lilly product to Lantus. Sanofi states that Lilly acknowledged three of the seven patents in question and said their new product would not conflict with Lantus prior to patent expiration.

Sanofi contends that not only does the Lilly product infringe upon the patents that they did acknowledge, but also upon those that it did not. Sanofi called for an injunction to the approval of Abasria until all patents in question have expired.

Abasria has already received approval recommendation from the European Committee for Medicinal Products for Human Use and the FDA accepted the NDA for the drug last month. Yesterday, the FDA also accepted the NDA for Toujeo, another novel insulin product submitted by Sanofi.

“Lilly is aware of the second lawsuit that Sanofi has filed against the company for alleged patent infringement with respect to LY2963016, Lilly and Boehringer Ingelheim’s insulin glargine product,” Tammy Hull of Lilly Diabetes told Endocrine Today. “We are reviewing the lawsuit, however, Lilly does not believe the application infringes any of the asserted patents.”

For more information: Sanofi-Aventis et. al. v. Eli Lilly and Company