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).
FDA approves follow-on insulin lispro Admelog
Biosimilars/News | Posted 19/01/2018 0 Post your comment
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].
Related articles
Sanofi receives tentative FDA approval for insulin lispro biosimilar
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
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.
Copyright – Unless otherwise stated all contents of this website are © 2018 Pro Pharma Communications International. All Rights Reserved.
Source: Sanofi, US FDA
Research
Long-term real-world safety experience of biosimilars confirms concept of biosimilarity
Budget impact analysis of Rixathon introduction in Chile for non-Hodgkin lymphoma
General
Biosimilar medicines on the Pharmaceutical Benefits Scheme in Australia
SBR issues consensus on interchangeability of reference products and biosimilars
Comments (0)
Post your comment