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Lilly receives European marketing OK for new insulin

September 10, 2014

European regulators have approved a long-lasting insulin from Eli Lilly and Co. and German drugmaker Boehringer Ingelheim that is the subject of patent-infringement litigation with French rival Sanofi.

Lilly said Wednesday that the European Commission granted marketing authorization for its product, named Abasria in Europe, to be used in treating diabetes in adults, adolescents and children ages 2 years and above.

Last month, the Food and Drug Administration gave a tentative approval to the insulin, named Basaglar in the United States. That is subject to a stay of more than two years due to the Sanofi litigation. The drugmaker has sued in U.S. federal court alleging that the Lilly product infringes on patents protecting its insulin Lantus. Lilly has denied the allegation.

A Lilly spokeswoman said the drugmaker also faces litigation with Sanofi in Europe but declined to elaborate.

The Lilly and Boehringer insulin is a biosimilar product that has the same amino acid sequence as Lantus.

Lantus garnered $7.8 billion in sales for Paris-based Sanofi in 2013.

Biosimilars are medicines similar to biologic drugs but not identical in the way generic drugs are copies of brand-name pills. Biologic drugs are complex, injected drugs manufactured from living cells, rather than by mixing chemical compounds together and turning them into pills.

Basaglar is designed to help control blood sugar between meals and at night.

Insulin helps people with diabetes, a chronic condition in which the body either does not make enough insulin to break down the sugar in foods or uses it inefficiently. Diabetes, which is becoming increasingly common worldwide, can cause early death or serious complications like blindness or heart disease.

Shares of Indianapolis-based Lilly climbed 23 cents, to $64.67 each, Wednesday morning, while broader trading indexes fell slightly. U.S.-traded shares of Sanofi fell 23 cents, to $55.57.

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