FDA accepts application for Merck’s follow-on insulin glargine

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FDA accepts application for Merck’s follow-on insulin glargine

Biosimilares/Novedades | Posted 02/09/2016 0 Post your comment

US pharma giant Merck announced on 5 August 2016 that its regulatory submission for its proposed follow-on insulin glargine product (MK-1293) had been accepted by the US Food and Drug Administration (FDA).

The application for the investigational follow-on biological insulin glargine candidate was submitted as a new drug application (NDA) via the 505(b)(2) regulatory pathway, which allows FDA to reference previous findings of safety and efficacy for an already-approved product (Lantus), in addition to reviewing findings from studies of MK-1293.

Insulin glargine is a long-acting basal insulin analogue, given once daily to help control the blood sugar level of those with diabetes. It consists of microcrystals that slowly release insulin, giving a long duration of action of 18 to 26 hours. Insulin glargine is indicated for the treatment of diabetes mellitus in adults, adolescents and children aged two years and above.

The product is a proposed follow-on product to Sanofi’s Lantus (insulin glargine), which had worldwide sales of US$6.4 billion in 2015. The patents on Lantus expired in 2014 in both Europe and the US [1]. Eli Lilly/Boehringer Ingelheim have already had a follow-on insulin glargine product, Basaglar, approved in the US in August 2014 [2].

The application is based on data from phase I studies assessing its pharmacokinetic and pharmacodynamic properties, as well as results of two phase III studies. One of the phase III studies was conducted in people with type 1 diabetes, while one was conducted in people with type 2 diabetes. Lantus (insulin glargine), the originator insulin glargine, was the active comparator in both studies.

Merck’s follow-on insulin glargine has been developed in collaboration with Samsung Bioepis, which is a joint venture between South Korean electronics giant Samsung and biotechnology company Biogen Idec. The companies made an agreement to develop, manufacture and commercialize MK-1293 back in February 2014 [3].

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References
1. GaBI Online - Generics and Biosimilars Initiative. Biologicals patent expiries [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Sep 2]. Available from: www.gabionline.net/Biosimilars/General/Biologicals-patent-expiries
2. GaBI Online - Generics and Biosimilars Initiative. FDA grants tentative approval for insulin treatment [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Sep 2]. Available from: www.gabionline.net/Biosimilars/News/FDA-grants-tentative-approval-for-insulin-treatment
3. GaBI Online - Generics and Biosimilars Initiative. Merck and Samsung Bioepis collaborate on biosimilar insulin [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Sep 2]. Available from: www.gabionline.net/Biosimilars/News/Merck-and-Samsung-Bioepis-collaborate-on-biosimilar-insulin

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Source: Merck