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EMA approves biosimilar insulin Posted 04/07/2014

The European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) announced on 27 June 2014 that it had recommended granting of marketing authorization for a biosimilar insulin glargine product (LY2963016).

The biosimilar insulin glargine, which will be called Abasria (LY2963016), is produced by US pharma giant Eli Lilly and its partner Boehringer Ingelheim. The drug is a biosimilar of French drugmaker Sanofi’s diabetes drug Lantus (insulin glargine). The drug is an investigational basal (long-acting) insulin for the treatment of type 1 and type 2 diabetes. Insulin glargine binds specifically to the human insulin receptor and results in the same pharmacological effects as human insulin. There are currently no biosimilars of insulin glargine available on the European market.

The announcement is good news for diabetes sufferers in Europe, especially after the disappointing withdrawal of the applications for three biosimilar insulin products by Marvel Life Sciences in November 2012 [1].

This is the first biosimilar insulin to receive a positive CHMP recommendation and will be Eli Lilly’s fourth insulin product to receive European Union approval. It most likely would not be the last, though. 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, as well as Eli Lilly’s Humalog (insulin lispro), 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].

The review of Abasria has taken almost one year; EMA first said that it was reviewing a biosimilar insulin product in its 4 July 2013 list of applications for new human medicines [4].

The CHMP opinion states that ‘studies have shown Abasria to have a comparable quality, safety and efficacy profile to Lantus (insulin glargine).’ Eli Lilly will be required, as with all biologicals, to implement a pharmacovigilance plan as part of the marketing authorization.

The CHMP’s recommendation for Abasria will now be referred to the European Commission which grants approval for the European Union, Norway and Iceland. The Commission’s final approval is anticipated by September 2014.

Eli Lilly and Boehringer Ingelheim also had new drug application (NDA) for their biosimilar insulin product (LY2963016) accepted by the US Food and Drug Administration in December 2013 [5]. Although, according to Eli Lilly’s press release, it seems that it will not be considered under the abbreviated biosimilars pathway in the US.

Related article
Biosimilars applications under review by EMA – April 2014

References
1. GaBI Online - Generics and Biosimilars Initiative. Marvel withdraws biosimilar insulin applications [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Jul 4]. 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 2014 Jul 4]. 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 Jul 4]. Available from: www.gabionline.net/Biosimilars/News/Sanofi-starts-biosimilar-insulin-trials
4. GaBI Online - Generics and Biosimilars Initiative. EMA reviewing biosimilar insulin application [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Jul 4]. Available from: www.gabionline.net/Biosimilars/News/EMA-reviewing-biosimilar-insulin-application
5. GaBI Online - Generics and Biosimilars Initiative. FDA to review insulin biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Jul 4]. Available from: www.gabionline.net/Biosimilars/News/FDA-to-review-insulin-biosimilar

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Source: Eli Lilly, EMA

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