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Sanofi's Insulin Aspart Biosimilar Receives Approval in Europe


The European Commission has granted market authorization to Sanofi for its insulin aspart biosimilar, making it the first approved biosimilar to NovoRapid for the region.

Sanofi has received marketing authorization for its insulin aspart biosimilar (Insulin aspart Sanofi) from the European Commission, becoming the first insulin aspart biosimilar to be approved in Europe.

Market authorization was granted on June 25 and Sanofi announced it on July 3.

“With Insulin aspart Sanofi, we will serve people with diabetes in a diverse range of age groups. This reflects our continued commitment to individualization of care for people with diabetes,” Alan Divanovic, MD, vice president of medical affairs at Sanofi, told Pharmacy Business.

The biosimilar references Novo Nordisk's NovoRapid and was approved for blood sugar control in adults, adolescents, and children aged 1 and older who have type 1 or type 2 diabetes.

The European Commission’s decision comes after the European Medicines Agency’s Committee for Human Medical Products issued a positive recommendation for approval in May 2020.

The approval was based on data from a clinical development project that involved more than 600 adult patients with type 1 or type 2 diabetes.

Sanofi investigators presented the study results from 3 late-breaking clinical trials at the American Diabetes Association 79th Scientific Sessions in June 2019, showing that Insulin aspart Sanofi was comparable to the reference product in pharmacokinetics, pharmacodynamics, safety, and efficacy.

Sanofi’s Growing Insulin Portfolio

This is Sanofi’s third rapid-acting insulin analog to be approved by European regulators. Its insulin glulisine originator (Apidra) was approved in Europe in 2004, and its insulin lispro follow-on product (Admelog) received European approval in 2017.

“By providing all 3 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,” Divanovic said.

Admelog was approved by FDA in 2017 and launched on the US market in April 2018.

Sanofi also released positive phase 3 clinical results for Toujeo, its follow-on insulin glargine product (Lantus), in pediatric patients in November 2019.

Sanofi is the maker of Lantus, an insulin glargine blockbuster product that is currently facing intense biosimilar competition in Europe and was the first insulin product to have a biosimilar approved there.

In December 2019, Sanofi announced that it would end its research and development efforts on diabetes and cardiovascular drugs in order to focus more on cancer immunotherapies and other biologics, but said that it will continue with its insulin business.

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