FDA grants tentative approval for insulin treatment

Biosimilars/News | Posted 22/08/2014 post-comment0 Post your comment

On 18 August 2014, the US Food and Drug Administration (FDA) granted tentative approval for a new insulin glargine product (LY2963016).

Insulin 1 V13C03

The insulin glargine, which will be called Basaglar (LY2963016), is produced by US pharma giant Eli Lilly and its partner Boehringer Ingelheim. The drug is intended to be a competitor to, and has the same amino acid sequence as, French drugmaker Sanofi’s diabetes drug Lantus (insulin glargine).

Approximately 29 million Americans and an estimated 382 million people worldwide have type 1 or type 2 diabetes. Type 2 diabetes is the most common type, accounting for an estimated 85% to 95% of all diabetes cases. Diabetes is a chronic condition that occurs when the body either does not properly produce, or use, the hormone insulin.

The application for approval of Basaglar was submitted to FDA using a New Drug Application (NDA) in December 2013 [1] and not via the abbreviated biosimilars pathway. The same product (LY2963016) was recommended for approved by the European Medicines Agency’s Committee for Medicinal Products for Human Use on 27 June 2014 [2]. In Europe the drug, which will be called Abasria, has been approved via an abbreviated biosimilars pathway.

Eli Lilly and Boehringer Ingelheim have only received tentative approval from FDA for Basaglar due to ongoing litigation filed by Sanofi, claiming patent infringement. This means that FDA cannot give final approval for Basaglar until the end of a 30-month automatic stay period, which ends in mid-2016, unless the court finds in favour of Eli Lilly and Boehringer Ingelheim earlier.

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1. GaBI Online - Generics and Biosimilars Initiative. FDA to review insulin biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Aug 22]. Available from: www.gabionline.net/Biosimilars/News/FDA-to-review-insulin-biosimilar
2. GaBI Online - Generics and Biosimilars Initiative. EMA approves biosimilar insulin [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Aug 22]. Available from: www.gabionline.net/Biosimilars/News/EMA-approves-biosimilar-insulin

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Source: Boehringer Ingelheim, Eli Lilly, FDA

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