EU CHMP recommends approval of Insulin lispro Sanofi (insulin biosimilar) to treat type 1 and 2 diabetes- Sanofi

Sanofi announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (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 type 1 or 2 diabetes and need insulin to keep their blood sugar level controlled, including those patients whose diabetes has just been diagnosed.

The recommendation is based on a clinical development program involving over 1,000 adults with type 1 or type 2 diabetes. This program comprised a pharmacokinetic / pharmacodynamic (PK/PD) Phase I study to evaluate the product's similarity in exposure and activity compared to insulin lispro 100 Units/mL as currently approved in the U.S. and EU1, two multi-center Phase IIIa clinical trials (SORELLA 12 and SORELLA 2) evaluating its safety and efficacy compared to insulin lispro 100 Units/mL as currently approved in the U.S. and EU in adults with type 1 or type 2 diabetes, and a safety study in insulin pumps in adults with type 1 diabetes.