EMA approval for biosimilar insulin glargine Semglee

Biosimilars/News | Posted 15/02/2018 post-comment0 Post your comment

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced on 25 January 2018 that it had recommended granting marketing authorization for the insulin glargine biosimilar Semglee.

20 AA010933

Semglee is produced by US generics giant Mylan Pharmaceuticals (Mylan) and partner India-based biologicals specialist Biocon. The pair submitted their application for their insulin glargine biosimilar (MYL 1501D) to EMA in November 2016 [1].

The product is a proposed biosimilar to Sanofi’s Lantus (insulin glargine), which had worldwide net sales of US$5.7 billion in 2016. The patents on Lantus expired in 2014 in both Europe and the US [2].

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 CHMP has recommended that Semglee be approved for the treatment of diabetes. The positive opinion will now be referred to the European Commission, which grants marketing authorizations for medicines in the European Union.

Biocon also received approval from Japan’s Ministry of Health, Labour and Welfare for its insulin glargine biosimilar in March 2016 [3].

Biocon and Mylan have a global partnership on biosimilars with phase III clinical trials ongoing for candidate biosimilars of adalimumab, bevacizumab, pegfilgrastim and trastuzumab [4].

Related articles
Biosimilars of insulin glargine

Insulin glargine biosimilar in US delayed until end 2016

References
1. GaBI Online - Generics and Biosimilars Initiative. Mylan and Biocon submit insulin glargine biosimilar to EMA [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Feb 15]. Available from: www.gabionline.net/Biosimilars/News/Mylan-and-Biocon-submit-insulin-glargine-biosimilar-to-EMA
2. Derbyshire M. Patent expiry dates for biologicals: 2016 update. Generics and Biosimilars Initiative Journal (GaBI Journal). 2017;6(1):27-30. doi:10.5639/gabij.2017.0601.006
3. GaBI Online - Generics and Biosimilars Initiative. Biocon receives Japanese approval for insulin glargine biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Feb 15]. Available from: www.gabionline.net/Biosimilars/News/Biocon-receives-Japanese-approval-for-insulin-glargine-biosimilar
4. GaBI Online - Generics and Biosimilars Initiative. Indian drugmakers make progress with candidate biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Feb 15]. Available from: www.gabionline.net/Biosimilars/News/Indian-drugmakers-make-progress-with-candidate-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: EMA, Mylan

comment icon Comments (0)
Post your comment
Most viewed articles
About GaBI
Home/About GaBI Posted 06/08/2009
EU guidelines for biosimilars
EMA logo 1 V13C15
Home/Guidelines Posted 08/10/2010