Posted by Michael Wonder on 20 May 2017
Sanofi receives CHMP recommendation for approval of insulin lispro biosimilar
19 May 2017 - Positive opinion based on a clinical development program involving over 1,000 people with type 1 or type 2 diabetes.
Sanofi announced today that the CHMP of the EMA has adopted a positive opinion for the marketing authorization of Insulin lispro Sanofi (insulin lispro 100 units/mL).
CHMP recommended the use of Insulin lispro Sanofi to treat adults and children who have diabetes and need insulin to keep their blood sugar level controlled, including those patients whose diabetes has just been diagnosed. This positive opinion is the company’s first major regulatory milestone for a biosimilar diabetes treatment.
