FDA approves follow-on insulin lispro Admelog

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FDA approves follow-on insulin lispro Admelog

Biosimilares/Novedades | Posted 19/01/2018 0 Post your comment

Pharma giant Sanofi announced on 11 December 2017 that the US Food and Drug Administration (FDA) had approved its follow-on version of Eli Lilly’s Humalog (insulin lispro).

Sanofi received tentative FDA approval for the company’s follow-on insulin lispro, Admelog, back in September 2017 [1].

Insulin lispro is a fast acting insulin analogue used to treat people living with type 1 or type 2 diabetes. Insulin lispro has one primary advantage over regular insulin for postprandial glucose control. It has a shortened delay of onset, allowing slightly more flexibility than regular insulin, which requires a longer waiting period before starting a meal after injection. Both types should be used in combination with a longer acting insulin for good glycaemic control.

Admelog was approved via FDA’s abbreviated 505(b)(2) pathway, not via the biosimilar pathway. The 505(b)(2) pathway allows sponsors to cite findings that previously approved drugs are safe or effective to support the product’s safety or effectiveness.

The Admelog clinical development programme involved more than 1,000 adults living with type 1 or type 2 diabetes. Admelog will be available in both vials and the SoloStar pen, which is the most-used disposable insulin pen platform in the US.

Admelog was also granted marketing authorization as a biosimilar, under the proprietary name, Insulin lispro Sanofi, by the European Commission in July 2017 [2].

Biosimilars approved in the US

References
1. GaBI Online - Generics and Biosimilars Initiative. Sanofi receives tentative FDA approval for insulin lispro biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Jan 19]. Available from: www.gabionline.net/Biosimilars/News/Sanofi-receives-tentative-FDA-approval-for-insulin-lispro-biosimilar
2. GaBI Online - Generics and Biosimilars Initiative. EMA approval for insulin and rituximab biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Jan 19]. Available from: www.gabionline.net/Biosimilars/News/EMA-approval-for-insulin-and-rituximab-biosimilars

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Source: Sanofi, US FDA