EMA reviewing biosimilar insulin application

Biosimilars/News | Posted 02/08/2013 post-comment0 Post your comment

According to EMA’s list of applications for new human medicines under evaluation by the Committee for Medicinal Products for Human Use released on 4 July 2013 the agency is now reviewing a new application for a biosimilar insulin product.

Insulin 1 V13C03

The biosimilar (LY2963016) is an investigational basal (long-acting) insulin for the treatment of type 1 and type 2 diabetes produced by Eli Lilly and Boehringer Ingelheim. The product is a biosimilar of Lantus (insulin glargine), which is produced by Sanofi.

Eli Lilly and Boehringer Ingelheim have studied LY2963016 in a comprehensive clinical development programme, which included pharmacokinetic and pharmacodynamic studies, as well as phase III studies in patients with type 1 and type 2 diabetes. Lantus (insulin glargine) was used as the active comparator.

During 2012, Lantus had estimated worldwide sales of US$6.12 billion making it a top-seller for Sanofi. Worldwide, Lantus accounts for around 80% of the market for long-acting, or basal insulins used to treat diabetes.

The news will come as a relief to diabetes sufferers in Europe, after the disappointing withdrawal of the applications for three biosimilar insulin products by Marvel LifeSciences in November 2012 [1].

In fact, the future looks bright for biosimilar insulin products. Generics giant Mylan and India-based Biocon have made an agreement to develop and market Biocon’s biosimilar versions of three insulin analogue products, which include Lantus (insulin glargine), as well as Eli Lilly’s Humalog (insulin lispro), and Novo Nordisk’s NovoLog (insulin aspart) [2]. Sanofi is also not being left behind, and announced in May 2013 that its biosimilar insulin projects (which most likely include biosimilars of Humalog and NovoLog) had entered into phase I of clinical development [3].

Related article

Generics applications under review by EMA – 2013 Q2


1.  GaBI Online - Generics and Biosimilars Initiative. Marvel withdraws biosimilar insulin applications [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2013 Aug 2]. Available from: www.gabionline.net/Biosimilars/News/Marvel-withdraws-biosimilar-insulin-applications

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 2013 Aug 2]. 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 2013 Aug 2]. Available from: www.gabionline.net/Biosimilars/News/Sanofi-starts-biosimilar-insulin-trials

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Source: Boehringer Ingelheim, EMA

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