Sanofi's Biosimilar Insulin Aspart Gets Green Light in EU

Alicia Ault


May 05, 2020

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended approval of a biosimilar insulin aspart (100 units/mL) manufactured by Sanofi.

The committee recommended the biosimilar, a fast-acting insulin analog, for use in individuals age 1 or older who have diabetes and require insulin. It is highly similar to NovoRapid, the reference product made by Novo Nordisk, and has comparable quality, safety, and efficacy, said the CHMP.

NovoRapid was approved in the European Union in 1999.

"Insulin aspart is an important and widely used treatment for people with diabetes who require rapid control of their blood sugar at mealtime," said Sandra Silvestri, MD, PhD, global head of medical, Sanofi General Medicines, in a company statement.

Sanofi said the CHMP recommendation was based on clinical trials, including the multicenter phase 3 Gemelli 1 study, involving more than 600 adults with type 1 or type 2 diabetes.

Full approval following a CHMP positive opinion is normally a formality and occurs within 60 days.

Other Biosimilar Insulins Available

A biosimilar of the fast-acting, meal-time insulin lispro Humalog (Lilly) is approved in the European Union, where it is known as Insulin lispro Sanofi.

The same product is approved in the United States, where it is known as Admelog. Until recently, such products were called "follow-ons" in the United States.

Two basal (long-acting) insulin glargine products, biosimilars to the reference product Lantus (Sanofi), are approved in Europe. These include Semglee (Mylan SAS), now approved in 40 countries, and Abasaglar (Lilly/Boehringer Ingelheim), approved in the European Union in 2014.

In the United States, Lilly and Boehringer Ingelheim's follow-on or "copycat" insulin glargine product, Basaglar, was approved in 2015.

As follow-ons, the US products were not, until recently, technically "interchangeable" with the brand-name products, and so pharmacists couldn't simply substitute them without a physician writing a new prescription.

However, the US Food and Drug Administration changed its regulatory scheme in late March to now deem those follow-ons as biosimilars, and they will be regulated as biological products, not drugs, going forward, with the advantage that biosimilars will be considered interchangeable with the original branded products.

It's not clear, however, how much cheaper biosimilar insulins will be, especially given that the few companies which develop and market insulin now have branded products of their own while also developing biosimilars of competitor products.

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