The European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for the marketing authorization of Sanofi’s insulin aspart product.
The EMA’s decision readies the biosimilar for a final decision by the European Commission (EC) in ‘the coming months’, Sanofi stated.
The biosimilar, insulin aspart 100 units/ml, is a version of Novo Nordisk’s NovoRapid, and would be used in the treatment of adults, adolescents and children aged one year and above who have diabetes, in order to manage their blood sugar levels.
If approved by the EC, the product would be the first biosimilar approved for the originator product.
Products designed to treat diabetes form a core part of Sanofi’s portfolio, and the biosimilar could become the third fast-acting insulin analog that the company has approved for use in Europe.
In full year 2019 results, Novo Nordisk posted NovoRapid/NovoLog worldwide sales of DKK 18bn ($2.6bn), a figure that had fallen from 2018 figures but still represented close to a fifth of the company’s sales within its diabetes and obesity unit.
For Sanofi, the potential approval marks a reversal, after its Lantus (insulin glargine) became the first insulin product to have a biosimilar approved for it on the European market.