Tuesday, July 16, 2013

Lilly and Boehringer Ingelheim file biosimilar Lantus for approval in Europe

The European Medicine agency has accepted for review Eli Lilly and Boehringer application for approval for biosimilar copy of Sanofi's Lantus (Insulin Glargine). Lantus generates about $1billion in annual sales in Western European nations. 

Lilly and Boehringer have submitted the MAA based on a Phase 3 head to head study that compared their biosimilar version LY2963016 with Lantus. 

Results from the Phase III EDITION I & II studies reported.

EDITION I evaluated once daily evening insulin LY2963016, vs. Lantus in 807 people with T2DM with challenging treatment needs who were using basal + mealtime insulin. The basal insulin was titrated to achieve fasting plasma glucose of 80-100 mg/dL. There were similar reductions in HbA1c from baseline to 6 months (primary endpoint; least squares mean change -0.83% (0.06) in both groups; difference 0%). 
 In addition, ~ 40% of patients who had uncontrolled glycaemic levels despite combined therapy (oral antidiabetic agents plus basal and prandial insulins) reached glycaemic control. LY2963016 was associated with a 21% reduction in severe or confirmed nocturnal hypoglycaemia from month 3 to month 6 (36.1% vs. 46.0%; RR 0.79; p=0.0045) and a lower occurrence of any nocturnal hypoglycaemic event during the 6-month study period (45.3% vs. 59.7%; RR 0.76; 95% Cl 0.66 to 0.87). 

EDITION II evaluated LY2963016 in 811 patients with T2DM treated with basal insulin plus oral antidiabetic therapy. Top-line results report insulin U300 achieved similar blood sugar reduction while fewer patients experienced night-time hypoglycaemic events vs Lantus



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