EMA approval for biosimilar insulin glargine Semglee Posted 15/02/2018

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.

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].

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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

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Source: EMA, Mylan

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