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.
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.
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.
This positive opinion is the company’s first major regulatory milestone for a biosimilar diabetes treatment.
Jorge Insuasty MD, Senior Vice President, Global Head of Development, Sanofi, said: “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.
“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.
He added: “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 authorisation for Insulin lispro Sanofi in the coming months.