Lilly, BI Gain US Approval for Long-Acting Insulin

The US Food and Drug Administration has approved Eli Lilly and Company’s and Boehringer Ingelheim’s Basaglar (insulin glargine injection) 100 units/mL, a long-acting insulin with an identical amino acid sequence to Sanofi’s Lantus, another U-100 insulin glargine. Lantus was Sanofi’s top-selling drug in 2014 with sales of EUR 6.3 billion ($6.8 billion).

Basagla is indicated to control high blood sugar in adults and children with Type 1 diabetes and adults with Type 2 diabetes. It is delivered via the prefilled Basaglar KwikPen. It is part of the diabetes alliance formed by Eli Lilly and Boehringer Ingehelheim in 2011.

The FDA approval follows Basaglar tentative US approval in August 2014, which was contingent upon patent-litigation resolution. Per the settlement agreement with Sanofi, Basaglar will be available in the US starting on December 15, 2016.

The US regulatory approval for Basaglar is the eleventh fo orldwide, with launches taking place in several countries this year, including under the trade name Abasaglar in Europe.

Basaglar will compete with Sanofi’s Lantus, which faced which faced patent expiry, effective in February 2015 in the US and in May 2015 in the European Union. Sanofi is positioning its next-generation long-acting insuling product, Touejo (insulin glargine [rDNA origin]. a basal insulin for treating Type 1 and Type 2 diabetes mellitus, which was approved in 2015, and is is a next-generation, once-daily basal insulin based on a broadly used molecule (insulin glargine), which is the active ingredient in Sanofi’s best-selling product, Lantus. Lantus had 2014 sales of EUR 6.3 billion ($7.2 billion). Potential Touejo’s sales are estimated at nearly $1.3 billion, according to industry estimates. Touejo was approved in the US in February 2015 and the European Union in April 2015 and was recently approved in Japan.

Source: Eil Lilly and Company

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