EU green lights first insulin biosimilar from Lilly, BI

The treatment, known as Abasria, is the first biosimilar insulin recommended for approval in the EU but it will face competition from Sanofi and Novo Nordisk insulin products. The insulin glargine recommended approval is a basal insulin, which is intended to provide long-lasting blood sugar control between meals and at night. It has the same amino acid sequence as Sanofi’s Lantus (insulin glargine), which made nearly $8bn worldwide last year, of which $1.1bn was from the EU.

“Studies have shown Abasria to have a comparable quality, safety and ​efficacy profile to Lantus​,” CHMP said in its opinion, noting that a pharmacovigilance plan for Abasria will be implemented as part of the marketing authorisation.

Molly McCully, spokeswoman for Lilly, told BioPharma-Reporter.com the company has extensive experience manufacturing insulin since 1923, and “remains committed to innovation in insulin therapy, introducing many insulin products and delivery devices in the last nine decades​.”

In 2012, Lilly announced plans to double its insulin and device manufacturing capacity​ at existing sites through 2017.

As far as delivery options, McCully noted that patients will have multiple choices for Abasria, including a pre-filled pen and cartridges for a reusable pen.

But Lilly will have to wait until after May 2015 to roll out its biosimilar on the EU market, which is when the patent on Lantus expires, according to Reuters​.

The financial impact of a European approval of a biosimilar for Lantus may also be limited as Europe accounted for only 14% of the product's global sales last year, according to Deutsche Bank analyst Mark Clark.

As far as the US is concerned, McCully told us that Lilly is not planning to seek approval of Abasria in the US as a biosimilar and instead filed a 505(b)(2) application with the FDA. The 505(b)(2) is a new drug application which contains full safety and effectiveness reports, but allows at least some of the information required for approval to come from studies not conducted by or for the applicant.

“The FDA is currently reviewing the NDA​,” McCully said.

Merck is the only other company with a biosimilar insulin glargine in development, according to the Biosimilarz blog. Although Sanofi is also developing a follow-on to Lantus, known as Toujeo, which Sanofi recently reported encouraging results in a Phase III clinical study.