Japanese approval for insulin glargine biosimilar

Biosimilars/News | Posted 30/01/2015 post-comment0 Post your comment

Partners Eli Lilly and Boehringer Ingelheim confirmed on 19 January 2015 that they had received Japanese regulatory approval for their biosimilar insulin glargine product (LY2963016).

Insulin 2 V13E10

The product is a basal (long-acting) insulin with the same amino acid sequence as French drugmaker Sanofi’s diabetes drug Lantus (insulin glargine). Eli Lilly and Boehringer Ingelheim believe this to be the first local biosimilar competition for the branded basal insulin analogue in Japan.

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 85−95% 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 partners received European Commission approval for their biosimilar insulin glargine product Abasria (LY2963016) in September 2014, a first for Europe [1]. The product (LY2963016) has also received tentative approval 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 [2].

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References
1.   GaBI Online - Generics and Biosimilars Initiative. European approval for biosimilar insulin [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Jan 30]. Available from: www.gabionline.net/Biosimilars/News/European-approval-for-biosimilar-insulin 
2.   GaBI Online - Generics and Biosimilars Initiative. FDA grants tentative approval for insulin treatment [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Jan 30]. Available from: www.gabionline.net/Biosimilars/News/FDA-grants-tentative-approval-for-insulin-treatment 

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Source: Eli Lilly, PharmAsiaNews

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