Positive opinion based on a clinical development program involving over 1,000 people with type 1 or type 2 diabetes
Sanofi announced recently 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 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.
“We welcome the CHMP positive opinion for Insulin lispro Sanofi and look forward to the final decision of the European Commission (EC),” said Jorge Insuasty MD, Senior Vice President, Global Head of Development, Sanofi. “Our 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.”
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 EU1, two multi-center Phase 3a 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.
“Insulin lispro is an important and widely-used treatment for people with diabetes who require rapid control of their blood sugar at mealtime,” said Peter Guenter, Executive Vice President and General Manager, Diabetes & Cardiovascular, Sanofi. “By broadening our portfolio of quality insulin options, we acknowledge our commitment to expand the affordability and sustainability of insulin treatments.”
The European Commission is expected to make a final decision on marketing authorization for Insulin lispro Sanofi in the coming months.
About Insulin lispro Sanofi (insulin lispro 100 Units/mL)
Insulin lispro Sanofi is a biosimilar of insulin lispro, a rapid-acting insulin analog, produced using recombinant DNA technology and has the identical amino acid sequence as its reference product. It is currently not approved by any regulatory authority. It was submitted to the European Medicines Agency (EMA) in September 2016.
Sanofi, a global healthcare leader, discovers, develops and distributes therapeutic solutions focused on patients' needs. Sanofi is organized into five global business units: Diabetes and Cardiovascular, General Medicines and Emerging Markets, Sanofi Genzyme, Sanofi Pasteur and Consumer Healthcare.