Eli Lilly & BI Win EU Marketing Authorization for Insulin Biosimilar

September 16, 2014

European regulators have approved Eli Lilly and Boehringer Ingelheim’s insulin glargine drug Abasria, a biosimilar version of Sanofi’s blockbuster product Lantus.

The joint product is the first insulin therapy approved under the European Medicines Agency’s 10 year-old biosimilar pathway, the companies said. The approval follows a positive June 26 recommendation from the EMA’s Committee for Medicinal Products for Human Use.

The companies didn’t say when they would launch Abasria in Europe. The EU patent on Lantus expires in May 2015, according to the analytics site GenericsWeb.

Abasria is a basal insulin with the same amino acid sequence as Lantus (insulin glargine injection), and clinical trials have shown similar efficacy and effectiveness between the therapies. The product will be made by Lilly and is indicated for long-lasting blood sugar control in patients with type 1 and type 2 diabetes. It will be available in both a pre-filled pen and cartridges for a reusable pen, Lilly and BI said.

The companies noted that while Abasria is an approved name in Europe, it’s not necessarily approved in other regions. Lilly and BI are now seeking a global trade name, which will be announced at a later date.

Meanwhile, Lilly and BI are waiting to launch the drug in the U.S. under the brand name Basaglar. The product won tentative FDA approval as an NDA last month, but marketing has been delayed by a patent infringement lawsuit filed by Sanofi. Insulin therapies in the U.S. are regulated as small molecule products rather than biologics, necessitating the NDA filing rather than a BLA.

Lantus generated more than $7 billion in global sales last year, according to Sanofi’s annual financial report. — Bryan Koenig

Originally appeared in Drug Industry Daily, the pharmaceutical industry’s number one source for regulatory news and information. Click here for more information.