The European Medicines Agency 's (EMA's) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for the marketing authorisation of Sanofi's insulin lispro.
Insulin lispro is intended to treat adults and children affected with diabetes and who need insulin to keep their blood sugar level under control.
It is a biosimilar diabetes treatment that can also be used to treat patients who are newly diagnosed with diabetes.
Sanofi Development senior vice-president and global head Dr Jorge Insuasty said: “We welcome the CHMP positive opinion for insulin lispro Sanofi and look forward to the final decision of the European Commission (EC).
“Our development of this investigational biosimilar product reflects Sanofi's expertise and long-term heritage in developing and manufacturing high-quality insulin for people with type 1 or type 2 diabetes and their physicians.”
The CHMP recommendation is based on a clinical development programme that involves more than 1,000 adults suffering from type 1 or type 2 diabetes.
The programme included a pharmacokinetic / pharmacodynamic (PK/PD) Phase I trial, two multicentre Phase IIIa clinical trials (SORELLA 12 and SORELLA 2), and a safety study in insulin pumps in adults with type 1 diabetes.
The PK/PD Phase I trial assessed the product's similarity in exposure and activity compared to insulin lispro 100 units per millilitre (units/mL) as currently approved in the US and the European Union (EU).
The Phase IIIa trials evaluated the safety and efficacy of the product compared to insulin lispro 100 units/mL as currently approved in the US and EU in adults with type 1 or type 2 diabetes.
Sanofi diabetes and cardiovascular executive vice-president and general manager Peter Guenter said: “Insulin lispro is an important and widely used treatment for people with diabetes who require rapid control of their blood sugar at meal times.
“By broadening our portfolio of quality insulin options, we acknowledge our commitment to expand the affordability and sustainability of insulin treatments.”
Over the coming months, the EC is expected to make a final decision on marketing authorisation for Sanofi's insulin lispro.