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ADA: Lilly/Boehringer insulin glargine matches Lantus

Biosimilar demonstrates equal efficacy to Sanofi’s big-selling diabetes treatment
ADA meeting

Lilly and Boehringer Ingelheim's plan to compete with Sanofi's big-selling Lantus are on course after the companies presented positive data on their own insulin glargine product, known as LY2963016.

The partners, who have been in a diabetes alliance since 2011, plan to sell a version of insulin glargine once the patent on Sanofi's treatment expires in the next few years.

In order to gain approval, however, Boehringer and Lilly have to demonstrate that their insulin glargine is equivalent to Sanofi's Lantus. This has been achieved through two phase III trials - one in type 1 diabetes and one in type 2 - presented this weekend at the American Diabetes Association meeting in San Francisco, US.

In both studies, LY2963016 managed its primary outcome of reducing blood sugar levels at a similar level to Lantus, while rates of adverse events, including hypoglycaemia, was also comparable.

Lilly and Boehringer also presented the results of several phase I trials, which demonstrated the pharmacokinetic and pharmacodynamic profiles of their insulin glargine. This covers such aspects as the amount of insulin in the blood, the action of the insulin and the length of time it remains in the body.

The results will support the drug's regional regulatory applications, for which there is some variance. In the EU, the drug is currently under review as a biosimilar product by the European Medicines Agency (EMA) under its specific pathway for new biosimilar treatments.

However, Boehringer and Lilly's insulin glargine is not officially a biosimilar in the US, despite being a copy of a biological medicine. Due to differences in the regulatory setup of the FDA, the drug is to be assessed via a new drug application rather than a biological licence application, meaning it legally must be classified as a whole new treatment rather than as a biosimilar copy.

It is uncertain whether this difference in definition will affect the drug's performance in either region. In any case the product is set to make a big impact in the diabetes world, offering direct competition to Lantus, which was Sanofi's biggest product in 2013 taking in just under $6bn in revenues.

Speaking to PMLiVE, Gwen Krivi, VP, Lilly diabetes development, explained that another insulin glargine would offer people with diabetes greater treatment choice.

“Whenever there is large population, as with diabetes patients, there are many different needs and wants," she said. "Different people react differently to different agents. By providing this new insulin glargine, we provide an important therapeutic choice for patients, payers and healthcare professionals.”

Krivi also confirmed that Sanofi is not taking the threat lying down and has mounted a legal challenge claiming that Lilly and Boehringer have already infringed its patent.

Article by
Thomas Meek

16th June 2014

From: Research



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