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BI/Lilly's “Biosimilar” Insulin Glargine Receives European Approval

Twitter summary: BI/Lilly’s #insulin glargine receives EU approval – “Abrasia” set to launch in mid-2015 as 1st ever “biosimilar” insulin in Europe

On September 10, Eli Lilly and Boehringer Ingelheim (BI) announced the European approval of their insulin glargine product, named Abrasia in Europe. Lilly/BI’s insulin glargine product is biologically similar to Sanofi’s Lantus (insulin glargine) and is the first insulin to be approved in Europe as a “biosimilar.” The “biosimilar” label reflects that Abrasia is created from the same protein sequence as Lantus and has a comparable glucose-lowering profile. Bi/Lilly’s insulin glargine received “tentative approval” from the FDA in August, but it will be branded under the name Basaglar in the US. The companies are working on a revised trade name for the product that can be either more similar or exactly the same across the globe. The FDA does not technically consider Basaglar to be a “biosimilar” insulin for regulatory reasons, though at diaTribe we like to think of it as a “non-biosimilar biosimilar.”

Abrasia will be available in Europe as a pre-filled pen (KwikPen) and in cartridges for a reusable pen. Abrasia cannot launch in Europe until Sanofi’s patent for insulin glargine expires, which will happen in mid-2015. In the US, the launch of Basaglar is currently delayed until mid-2016 due to a lawsuit between Sanofi and BI/Lilly over Lantus patent infringement.

An advantage of biosimilars could well be potentially lower prices for patients, though we don’t know anything concrete about Abrasia's pricing yet. As we discussed in our recent conference pearls, insulin prices have increased significantly in recent years. The introduction of Abrasia/Basaglar and other future biosimilar insulins (such as from Merck and Mylan/Biocon) to the market may potentially help make insulin more affordable over time. –AJW