Sanofi’s insulin aspart has received marketing authorisation in EU, becoming the first biosimilar approved for the originator product in Europe.
The product recently got ‘positive opinion’ from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA).
Insulin aspart rounds out Sanofi’s insulin portfolio which already includes two rapid-acting insulin analogs approved by European regulators. Their latest nod, Sanofi said, would help the company serve adults, adolescents and children aged one year and above who have diabetes.
Alan Divanovic at Sanofi said: “Insulin aspart Sanofi adds to the broad range of rapid-acting therapies within our portfolio, which also includes insulin glulisine and insulin lispro.
“With Insulin aspart Sanofi, we will serve people with diabetes in a diverse range of age groups. This reflects our continued commitment to individualisation of care for people with diabetes.”
Cyril Grandchamp-Desraux, Sanofi’s Global Head of Diabetes, said: “By providing all three rapid-acting insulin options in glulisine, lispro and aspart, Sanofi is expanding the affordability and sustainability of insulin treatments, giving payers, physicians and patients more flexibility.”
The first insulin aspart biosimilar in EU is approved in cartridge and pre-filled pen configurations, the compnay said.
