Insulin biosimilar Semglee gains EC and Australian approval

Biosimilars/News | Posted 30/03/2018 post-comment0 Post your comment

India-based Biocon and US-based partner Mylan announced on 28 March 2018 that they had received European Commission (EC) and Australian approval for their co-developed insulin glargine biosimilar, Semglee.

Diabetes V14K06

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 approval by the EC is for Semglee at a dose of 100 IU/mL as a 3 mL prefilled pen for patients with diabetes and follows the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) positive recommendation on 25 January 2018 [1].

In addition, Australia’s drug regulator, the Therapeutic Goods Administration (TGA), also approved Semglee at a dose of 100 IU/mL as a 3 mL prefilled pen for patients with diabetes in Australia.

Diabetes is the fastest growing chronic condition in the world and the prevalence of this disease is increasing among all ages. In Europe, the number of diabetics is expected to grow to 38 million by 2030, while in Australia it currently affects nearly two million people, according to European Union (EU) and Diabetes Australia data, respectively.

Mylan plans to launch Semglee in Australia later in 2018 and expects to begin launching the product across various markets in Europe in the second half of 2018.

The EC approval of Semglee applies to all 28 EU Member States and the European Economic Area (EEA) Member States of Norway, Iceland and Liechtenstein.

In addition to these approvals, Biocon and Mylan say that marketing applications for Semglee have been submitted in Canada and the US and are also planned for key Emerging Markets.

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1. GaBI Online - Generics and Biosimilars Initiative. EMA approval for biosimilar insulin glargine Semglee []. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Mar 30]. Available from:

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Source: Biocon, Mylan

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