Japanese approval for insulin glargine biosimilar

Generics and biosimilars Initiative

Building trust in cost-effective treatments

Inscribirse
eng / esp

Japanese approval for insulin glargine biosimilar

Biosimilares/Novedades | Posted 30/01/2015 0 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).

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].

Europe–Japan cooperation on generics and biosimilars regulation

Biosimilars approved in Japan

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

Permission granted to reproduce for personal and non-commercial use only. All other reproduction, copy or reprinting of all or part of any ‘Content’ found on this website is strictly prohibited without the prior consent of the publisher. Contact the publisher to obtain permission before redistributing.

Source: Eli Lilly, PharmAsiaNews