Sanofi’s biosimilar insulin lispro recommended for EU approval

Sanofi has announced that its new biosimilar version of insulin lispro has been recommended for European regulatory approval.

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has adopted a positive opinion on the marketing authorisation of insulin lispro as a means of controlling blood sugar levels in adults and children with diabetes.

This represents Sanofi's first major regulatory milestone for a biosimilar diabetes treatment, with the recommendation based on a clinical development programme involving more than 1,000 adults with type 1 or type 2 diabetes.

The European Commission is expected to make a final decision on marketing authorisation for Sanofi's version of insulin lispro in the coming months.

Peter Guenter, executive vice-president and general manager for Sanofi's diabetes and cardiovascular business, said: "By broadening our portfolio of quality insulin options, we acknowledge our commitment to expand the affordability and sustainability of insulin treatments."

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