Insulin glargine biosimilar approved in Europe

Lilly and Boehringer Ingelheim have gained EU approval for their biosimilar version of Sanofi’s blockbuster insulin product Lantus (insulin glargine).

The Europe-wide approval is the first ever insulin treatment licensed through the European Medicines Agency’s biosimilar pathway, and the fourth diabetes product approved in the EU from the Lilly-Boehringer Ingelheim partnership.

The companies will now try to seize as much of the existing insulin analogue market as possible from the incumbent companies, including Sanofi, which leads the market with Lantus. The product earned 3 billion euros in the first half of 2014, a rise of nearly 15% on the same period last year.

The success of Lilly and Boehringer’s biosimilar will depend partly on how well they can convince doctors and patients that the drug is as good as Sanofi’s original drug – and partly on how much cheaper its version is in comparison to Lantus.  However this erosion is not expected to be rapid, and most prescriptions of the biosimilar are likely to come from first-time prescriptions of insulin for a patient.

Sanofi has successfully blocked its rivals’ product from reaching the US market by using a series of legal measures. Sanofi is suing Lilly for alleged infringement of patents, a move that will keep the competitor’s biosimilar off the market until at least mid-2016.

“The marketing authorisation for this insulin glargine product in Europe is a significant achievement for the Lilly-Boehringer Ingelheim Alliance. We believe that insulin glargine will continue to be widely used for many years, and Lilly and Boehringer Ingelheim are committed to addressing the needs of people living with diabetes and providing support beyond the medicine,” said Enrique Conterno, president, Lilly Diabetes.

The Alliance’s insulin glargine product is a basal insulin with the same amino acid sequence as Lantus (insulin glargine) and is intended to provide long-lasting blood sugar control between meals and at night. Lilly/Boehringer Ingelheim’s insulin glargine product will be available in a pre-filled pen and cartridges for a reusable pen.

The marketing authorisation for the Alliance’s insulin glargine product is based upon a comprehensive clinical data programme, which showed it has similar efficacy and safety compared to Lantus in people with type 1 and type 2 diabetes. The application included results from pharmacokinetic and pharmacodynamic studies, as well as Phase III studies in patients with type 1 and type 2 diabetes.

The Lilly-BI product will carry the brand name of Abasria in Europe, but may have to be known by a different name in other territories. The companies say they want to have a global trade name for their insulin glargine product, to be announced at a later date.

Meanwhile, Sanofi is working on its own next-generation insulin in an attempt to hold onto its market leading position.

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