European approval for biosimilar insulin

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European approval for biosimilar insulin

Biosimilares/Novedades | Posted 12/09/2014 0 Post your comment

Partners Eli Lilly and Boehringer Ingelheim, announced on 10 September 2014 that they had received European Commission (EC) approval for its biosimilar insulin glargine product Abasria (LY2963016), a first for Europe.

The news follows the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) positive recommendation of 27 June 2014 [1].

The biosimilar insulin glargine product is a basal (long-acting) insulin with the same amino acid sequence as French drugmaker Sanofi’s diabetes drug Lantus (insulin glargine). Abasria is intended to provide long-lasting blood sugar control between meals and at night and will be available in a pre-filled pen and cartridges for a reusable pen.

The marketing authorization for Abasria is based upon a comprehensive clinical data programme, which showed it has similar efficacy and safety compared to Lantus in people with type 1 and type 2 diabetes. The application included results from pharmacokinetic and pharmacodynamic studies, as well as phase III studies in patients with type 1 and type 2 diabetes.

This is the first biosimilar insulin to receive marketing authorization in Europe, but it will not be the last. Other companies working on biosimilar insulin products include generics giant Mylan and India-based Biocon [2], as well as Sanofi [3].

Eli Lilly and Boehringer Ingelheim also received tentative approval for their insulin glargine product (LY2963016) from the US Food and Drug Administration (FDA). The application for approval of the drug, however, which will be called Basaglar in the US, was submitted to FDA using a new drug application and not via the abbreviated biosimilars pathway [4].

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References
1.   GaBI Online - Generics and Biosimilars Initiative. EMA approves biosimilar insulin [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Sep 12]. Available from: www.gabionline.net/Biosimilars/News/EMA-approves-biosimilar-insulin
2.   GaBI Online - Generics and Biosimilars Initiative. Mylan and Biocon to partner on insulin products [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Sep 12]. Available from: www.gabionline.net/Biosimilars/News/Mylan-and-Biocon-to-partner-on-insulin-products
3.   GaBI Online - Generics and Biosimilars Initiative. Sanofi starts biosimilar insulin trials [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Sep 12]. Available from: www.gabionline.net/Biosimilars/News/Sanofi-starts-biosimilar-insulin-trials
4.   GaBI Online - Generics and Biosimilars Initiative. FDA grants tentative approval for insulin treatment [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Sep 12]. Available from: www.gabionline.net/Biosimilars/News/FDA-grants-tentative-approval-for-insulin-treatment

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Source: Eli Lilly, Boehringer Ingelheim