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FDA approves Lilly/Boehringer Lantus biosimilar

Published on 17/12/15 at 03:52pm
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The FDA has approved Eli Lilly and Boehringer Ingelheim’s long-acting insulin Basaglar (insulin glargine injection – a biosimilar to rival Sanofi’s blockbuster Lantus – for type 1 and 2 diabetes.

The Administration had tentatively approved the product in August 2014, but did not give full approval due to a lawsuit between Sanofi and Lilly over the latter’s cheaper version of the French company’s bestselling product. The companies reached a settlement in September, with Sanofi granting Lilly a license to sell the drug globally in Kwikpen devices. The product will launch in the US in December 2016.

Although Lantus brought in global sales of $8 billion in 2014, sales have been hit this year by the European launch of Basaglar, where it is marketed as Abasaglar. In the nine months to Q3, sales were $4.85 billion. 

The FDA said Lilly and Boehringer demonstrated that Basaglar was sufficiently similar to Lantus to scientifically justify reliance, with data from two clinical trials enrolling 534 and 744 patients with type 1 and 2 diabetes mellitus respectively used in the company’s application. 

However, despite being widely considered a biosimilar, the FDA's approval does not acknowledge it as such, as the agency reserves the term for products licensed under a particular provision of the Public Health Service Act (PHSA), and the reference product Lantus was originally approved under a different act.

"Lilly has a long history of developing and manufacturing insulin, having introduced the world's first commercial insulin more than 90 years ago," says David Kendall, vice president of global medical affairs at Lilly Diabetes. "Basaglar will be a welcome addition to our insulin and alliance portfolios, offering an option for people with diabetes who may need a long-acting insulin."

"The Basaglar FDA approval marks the first insulin therapy to be approved in the U.S. as part of our alliance with Lilly and broadens our portfolio of treatment options for people with type 1 and type 2 diabetes," says Paul Fonteyne, president and chief executive, Boehringer Ingelheim. "We remain committed to the care of people with diabetes and look forward to a successful US launch of Basaglar."

Basaglar is the latest product to come from the Lilly/Boehringer diabetes alliance, which was originally announced in 2011. Depending on geographies, the companies either co-promote or separately promote the respective molecules each contributed to the alliance.

This latest regulatory approval is the 11th for Basaglar worldwide, with launches taking place in several countries this year.

Joel Levy

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