Eli Lilly and Boehringer Ingelheim announced on 26 August 2015 the UK launch of their biosimilar insulin glargine, Abasaglar.
Abasaglar is a once-daily injectable licensed to treat diabetes in adults, adolescents and children aged two years and above. It is designed to be taken once per day, at the same time each day, to lower blood glucose levels. It is not indicated to treat diabetic ketoacidosis.
The biosimilar is available in cartridges for use in Lilly’s HumaPen Savvio and in the latest KwikPen device. Each cartridge/KwikPen contains 300 units of the biosimilar insulin in 3 mL of solution. It will be available for prescription from September 2015 at a cost of GBP 35.28 for five cartridges or KwikPens.
Abasaglar was approved by the European Medicines Agency (EMA) in September 2014 following evidence from phase III studies that showed a similar efficacy and safety profile to Sanofi’s originator product, Lantus [1].
This is the first biosimilar insulin to receive marketing authorization in Europe, but it will not be the last. EMA is currently reviewing another biosimilar insulin application [2]. Other companies known to be working on biosimilar insulin products include generics giant Mylan, India-based Biocon [3], as well as Sanofi [4].
Partners Eli Lilly and Boehringer Ingelheim also received Japanese regulatory approval for their biosimilar insulin glargine product (LY2963016) in January 2015 [5]. While more recently Australia’s Pharmaceutical Benefits Advisory Committee (PBAC) gave a positive recommendation for the listing of the companies’ biosimilar insulin glargine, Basaglar, in the country’s Pharmaceutical Benefits Scheme (PBS) [6].
Mr Jeremy Morgan, International Vice President of Lilly Diabetes, said ‘While basal insulin has been a mainstay of diabetes treatment for many years, there are still challenges for patients when it comes to embracing and beginning insulin treatment as part of their daily routine. We provide distinctive resources and tools to help support patients throughout their insulin initiation. This, added to our wealth of experience in diabetes allows us to offer Lilly medicines to a broad spectrum of people with diabetes at most stages of their treatment journey.’
Related articles
Biosimilars applications under review by EMA – August 2015
FDA grants tentative approval for insulin treatment
References
1. GaBI Online - Generics and Biosimilars Initiative. European approval for biosimilar insulin [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Sep 18]. Available from: www.gabionline.net/Biosimilars/News/European-approval-for-biosimilar-insulin
2. GaBI Online - Generics and Biosimilars Initiative. Biosimilars applications under review by EMA – August 2015 [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Sep 18]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-applications-under-review-by-EMA-August-2015
3. GaBI Online - Generics and Biosimilars Initiative. Mylan and Biocon to partner on insulin products [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Sep 18]. Available from: www.gabionline.net/Biosimilars/News/Mylan-and-Biocon-to-partner-on-insulin-products
4. GaBI Online - Generics and Biosimilars Initiative. Sanofi starts biosimilar insulin trials [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Sep 18]. Available from: www.gabionline.net/Biosimilars/News/Sanofi-starts-biosimilar-insulin-trials
5. GaBI Online - Generics and Biosimilars Initiative. Japanese approval for insulin glargine biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Sep 18]. Available from: www.gabionline.net/Biosimilars/News/Japanese-approval-for-insulin-glargine-biosimilar
6. GaBI Online - Generics and Biosimilars Initiative. Australian approval for biosimilar insulin [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Sep 18]. Available from: www.gabionline.net/Biosimilars/News/Australian-approval-for-biosimilar-insulin
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