CHMP recommends approval of Sanofi's biosimilar version of Eli Lilly's Humalog

Sanofi announced Friday that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion regarding a filing seeking approval of its biosimilar version of Eli Lilly's Humalog (insulin lispro). The French drugmaker noted that the decision "is the company's first major regulatory milestone for a biosimilar diabetes treatment."

According to Sanofi, the CHMP recommended the use of the therapy, dubbed Insulin lispro Sanofi, to treat adults and children who have diabetes and need insulin to keep their blood glucose level controlled, including those patients whose diabetes has just been diagnosed. The French company added that its filing, submitted in September last year, is based on a clinical development programme involving over 1000 adults with type 1 or type 2 diabetes. Sanofi noted that the programme included two Phase IIIa studies evaluating safety and efficacy compared to Humalog, as well as a safety study in insulin pumps in adults with type 1 diabetes.

The EMA indicated that Insulin lispro Sanofi has been found to be "highly similar" to Humalog, with data showing that it has "comparable quality, safety and efficacy" to Eli Lilly's product. Humalog, which was approved in Europe in 1996, generated global sales of $708.4 million in the first quarter, topping analyst estimates of $638 million.

For more information on biosimilars, see Biosimilar Index: Tracking the Biosimilar Development Landscape.

To read more Top Story articles, click here.