November 2018 has seen the launch of insulin glargine biosimilars in both the UK and South Korea.
South Korea-based GC Pharma (formerly Green Cross) announced on 8 November 2018 that it had launched its insulin glargine biosimilar Glarzia in South Korea.
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.
Glarzia Prefilled Pen is a biosimilar of Sanofi’s Lantus (insulin glargine). GC Pharma gained approval for Glarzia from the Korean Ministry of Food and Drug Safety (MFDS) in March 2018 [1]. The product was developed by Indian drugmaker Biocon. Under a licensing deal made in 2016, GC Pharma holds exclusive sales marketing rights for Glarzia in Korea.
GC Pharma plans to supply the treatment to hospitals and local clinics at a price of Won 10,878 (US$9.7), which represents an 83% discount compared to the originator biological, Lantus.
GC signed a promotional and wholesale agreement with Handok Pharmaceutical in January 2018, in which Handok will be responsible for domestic marketing and sales activities for Glarzia.
On 14 November 2018, US-based generics giant Mylan Pharmaceuticals (Mylan) and Indian biosimilars major Biocon announced that they had launched their insulin glargine biosimilar Semglee in the UK.
Semglee Prefilled Pen 100 units/mL is a biosimilar of Sanofi’s Lantus (insulin glargine). Biocon and Mylan gained European Commission (EC) and Australian approval for Semglee in March 2018 [2].
Diabetes is a growing healthcare problem worldwide. In Europe alone, 58 million people have diabetes, which is predicted to rise to almost 67 million by 2045 [3]. In the UK, almost 3.7 million people have been diagnosed with diabetes and a further 12.3 million people are at increased risk of type 2 diabetes [4]. If nothing changes, it is estimated that more than five million people will have diabetes in the UK by 2025 [5].
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References
1. GaBI Online - Generics and Biosimilars Initiative. Insulin glargine biosimilar gains South Korean approval [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Nov 23]. Available from: www.gabionline.net/Biosimilars/News/Insulin-glargine-biosimilar-gains-South-Korean-approval
2. GaBI Online - Generics and Biosimilars Initiative. Insulin biosimilar Semglee gains EC and Australian approval [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Nov 23]. Available from: www.gabionline.net/Biosimilars/News/Insulin-biosimilar-Semglee-gains-EC-and-Australian-approval
3. International Diabetes Federation. IDF Diabetes Atlas, 8th ed. International Diabetes Federation: Brussels, Belgium; 2015.
4. Diabetes UK. Facts and Figures [homepage on the Internet]. [cited 2018 Nov 23]. Available from: www.diabetes.org.uk/professionals/position-statements-reports/statistics
5. Diabetes UK. Facts and Stats [homepage on the Internet]. [cited 2018 Nov 23]. Available from: www.diabetes.org.uk/resources-s3/2017-11/diabetes-key-stats-guidelines-april2014.pdf
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Source: Diabetes UK, IDF, Korea Biomedical Review, Mylan
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