CHMP Recommends to approve Sanofi’s Insulin Lispro Biosimilar

Sanofi announced that the CHMP (Committee for Medicinal Products for Human Use) of the EMA (European Medicines Agency) recommended the use of Insulin lispro Sanofi (insulin lispro 100 Units/mL) 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. Along with that CHMP also shown a positive opinion for the marketing authorization of Insulin which is expected to  be finalised in coming months.

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 1 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 EU, two multi-center Phase 3a clinical trials (SORELLA 1 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.

Sanofi’s senior VP and Global Head of Development, Jorge Insuasty said that they welcome the CHMP positive opinion for Insulin lispro Sanofi and look forward to the final decision of the European Commission (EC). Their development of this investigational biosimilar product reflects Sanofi’s expertise and long-term heritage in developing and manufacturing high-quality insulins for people with type 1 or type 2 diabetes and their physicians.