EC approval for Sanofi’s insulin aspart biosimilar Posted 31/07/2020

The European Commission (EC) has issued marketing authorization for Sanofi’s insulin aspart biosimilar, which references Novo Nordisk’s product NovoLog and is used to treat type 1 and 2 diabetes.

Insulin aspart is a manufactured insulin product administered by injection which is used to control blood sugar in people with type 1 and type 2 diabetes. It works more rapidly than normal human insulin (acting within 15 minutes) and effects last for 3–5 hours. The originator product is produced by Novo Nordisk and sold as NovoLog.

Sanofi received a recommendation of approval from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) on 30 April 2020 [1]. The recommendation was based on data from more than 600 people with type 1 or type 2 diabetes, including a pharmacokinetic/pharmacodynamic (PK/PD) phase 1 study and a multicentre phase III clinical trial.

Sanofi has now received final approval from the EC which will allow it to launch the insulin aspart biosimilar on European markets. The product is indicated for adults, adolescents and children aged one year and older who have diabetes and is approved in both cartridge and pre-filled pen presentations.

The approval was granted on 25 June 2020 and announced by Sanofi on 3 July 2020. Sanofi’s product is the first insulin aspart biosimilar to receive approval in the European Union.

Commenting on the approval, Dr Alan Divanovic, Vice President of medical affairs at Sanofi, said: ‘Insulin aspart Sanofi adds to the broad range of rapid-acting therapies within our portfolio, which also includes insulin glulisine and insulin lispro. 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’.

Cyril Grandchamp-Desraux, Global Head of Diabetes, Sanofi General Medicines, added: ‘Insulin aspart is the most widely used rapid-acting insulin, representing the standard of care for the millions of people needing to control blood sugar at mealtimes. By providing all three 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’.

This is Sanofi’s third rapid-acting insulin analogue to be approved in Europe. According to EMA’s latest list of applications for biosimilars under review, the agency is also reviewing a second insulin aspart biosimilar [2].

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References
1. GaBI Online - Generics and Biosimilars Initiative. EMA recommends approval of Sanofi’s insulin aspart biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Jul 31]. Available from: www.gabionline.net/Biosimilars/News/EMA-recommends-approval-of-Sanofi-s-insulin-aspart-biosimilar
2. GaBI Online - Generics and Biosimilars Initiative. Biosimilars applications under review by EMA – July 2020 [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Jul 31]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-applications-under-review-by-EMA-July-2020

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Source: EMA

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