FDA Gives “Tentative Approval” to BI/Lilly’s insulin glargine Basaglar – Full Approval Pending Lawsuit with Sanofi

Twitter summary: FDA grants “tentative approval” to Lilly/BI’s Basaglar – new insulin option will be an alternative to Lantus in future

On August 18, Eli Lilly and Boehringer Ingelheim (BI) announced that the FDA granted “tentative approval” to Basaglar (insulin glargine injection) for type 1 and type 2 patients. Basaglar is biologically similar to Sanofi’s Lantus (insulin glargine), including the same protein sequence and a similar glucose-lowering profile – in our view, patients can think of it as an alternative form of Lantus. While there is no information yet on the pricing for Basaglar, we speculate that it will be at least slightly cheaper than both Lantus and Novo Nordisk’s Levemir (insulin detemir), which at retail value cost $430.99 and $380.99, respectively, for a carton of five pens at a local Walgreen’s pharmacy. Currently, both Lantus and Levemir are protected under patents that prevent competition and enable higher pricing. Once these patents expire (the Lantus patent expires in 2015), other companies are free to sell “biosimilar” versions of the same insulins. Although the FDA does not officially call Basaglar a biosimilar for regulatory reasons, although it is considered a biosimilar in Europe, and here at diaTribe, we’re calling it a “non biosimilar biosimilar”!

What does a “tentative” approval mean? That’s a good question. The FDA approval is “tentative” due to a lawsuit between Lilly/BI and Sanofi that we wrote about last spring in diaTribe #62 – Sanofi has alleged that the new version of Lantus infringes the original patent. The lawsuit will delay Basaglar’s full approval in the US until mid-2016, unless the court rules in favor of Lilly/BI before then. Basaglar is expected to receive full approval in Europe by the end of this month, though it will be marketed under a different name. Big picture, despite the lawsuit, we think FDA spoke volumes by moving to approve it so fast and this may augur well for other biosimilars though it is very early to say that – we think this one moved so quickly given Lilly’s long history as an insulin pioneer.

As patents for insulins expire, more companies can move into the insulin market, driving competition up and hopefully, perhaps providing more affordable alternatives. Other companies aside from Lilly/BI have already tossed their hats into the ring – Merck and Samsung Bioepsis are currently enrolling participants for a phase 3 trial of their insulin glargine product MK-1293, and Biocon’s version of insulin glargine (Basalog) is already approved in over ten countries worldwide. Many more patients need insulin than can currently afford it and we look forward to having more options available for patients. –AJW/ER/KC