The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion for insulin lispro 100 Units/mL (Insulin lispro Sanofi).
The product is a biosimilar (ie, is "highly similar to") of Humalog (Lilly), which has been licensed in the European Union since April 1996.
The full indication is: "For the treatment of adults and children with diabetes mellitus who require insulin for the maintenance of normal glucose homeostasis. Insulin lispro Sanofi is also indicated for the initial stabilization of diabetes mellitus."
The decision was based on four Sanofi-led clinical trials involving more than 1000 adults with type 1 or type 2 diabetes. These were a phase 1 pharmacokinetic/pharmacodynamic study to ascertain the product's similarity in exposure and activity to the currently licensed insulin lispro product, two multicenter phase 3a trials evaluating safety and efficacy compared with the current lispro, and an additional safety study in insulin pumps in adults with type 1 diabetes.
Insulin lispro is a bolus, "short-acting" insulin for use at mealtimes and in insulin pumps. A previous application for a biosimilar of the originator product, Humalog — called Solumarv (Marvel LifeSciences) — was rejected by the CHMP in 2015.
Lilly has already had a biosimilar version of the long-acting insulin glargine (Lantus, Sanofi), approved in the European Union and United States. In Europe, this is known as Abasaglar and in the United States as Basaglar.
"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, in a company statement.
"By broadening our portfolio of quality insulin options, we acknowledge our commitment to expand the affordability and sustainability of insulin treatments."
The European Commission normally authorizes products that are given a positive opinion by the CHMP within a couple of months.
The CHMP also issued positive opinions for three other biosimilar medicines, all containing rituximab.
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Cite this: European Medicines Agency Backs Biosimilar Insulin Lispro - Medscape - May 22, 2017.