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Last update: 27 November 2020
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 originator product, Sanofi’s Lantus (insulin glargine), was approved by the US Food and Drug Administration (FDA) in April 2000 and by the European Medicines Agency (EMA) in June 2000 [1]. Lantus generated an estimated US$6.4 billion in net sales income globally for Sanofi in 2015, before the advent of biosimilars.
The patents on Lantus expired in 2014 in both Europe and the US [1]. Some of the insulin glargine biosimilars and non-originator biologicals approved or in development are presented in Table 1.
| Table 1: Biosimilars and non-originator biologicals* of insulin glargine approved or in development | ||
| Company name, Country | Product name | Stage of development |
| Biocon/Mylan, India*/USA | Basalog/Semglee (MYL‑1501D) | Similar biologic’ launched in India in 2009 [2]. Received Japanese approval in March 2016 [3] and launched in July 2016. Approved by EC and Australia’s TGA in March 2018 [4, 5], and by FDA in June 2020 [6]. Launched in South Korea and the UK in November 2018 [7] and in Australia in October 2019 [8]. |
| Eli Lilly/Boehringer Ingelheim, USA/Germany | Abasaglar/ Basaglar (LY2963016) | Approved by EC in September 2014 [4], by FDA in August 2014 [6], by Japan in January 2015 [3] and by Australia in May 2015 [5]. Launched in Korea in April 2017 [9] |
| Gan & Lee, China | Basalin | Copy biological launched in China in 2005 |
| GC Pharma (Biocon), South Korea (India*) | Glarzia | Received Korean approval in March 2018 [9, 10]. Launched in South Korea in November 2018. |
| Kalbe Pharma, Indonesia* | - | Copy biological launched in Indonesia March 2017 [11] |
| Polus Biopharm, South Korea | PDP808 | Primary target |
| Samsung Bioepis, South Korea | Lusduna (SB9/MK 1293) | Approved by EU in January 2017 [4]. Tentative approval for follow-on biological granted by FDA in July 2017 [6]. Merck pulled out of deal in October 2018 [12] |
| Wockhardt, India* | Glaritus | ‘Similar biologic’ launched in India in March 2009 [2] |
|
EC: European Commission; EMA: European Medicines Agency; EU: European Union; FDA: US Food and Drug Administration; TGA: Therapeutic Goods Administration *See editor’s comment. |
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Eli Lilly/Boehringer Ingelheim’s application for approval of its insulin glargine product in the US, called Basaglar, was submitted to FDA using a new drug application and not via the abbreviated biosimilars pathway. Similarly, Samsung Bioepis/Merck’s application for approval of its insulin glargine product (SB9/MK-1293) in the US was also submitted to the FDA using a new drug application and not via the abbreviated biosimilars pathway [13]. Merck gained tentative approval, pending the resolution of patent litigation, for Lusduna from the FDA as a follow-on biological in July 2017 [6]. However, Merck pulled out of its deal with Samsung Bioepis for Lusduna in October 2018 [12]..
Editor’s comment
European Medicines Agency regulatory requirements ensure the same high standards of quality, safety and efficacy for biosimilars as for originator biologicals, and also include a rigorous comparability exercise with the reference product but they are not universally accepted by regulatory bodies outside of the European Union (EU). It should be noted that and ‘copy biologicals’ approved in China/Indonesia and ‘similar biologics’ approved in India might not have been authorized if they had been subjected to the strict regulatory processes required for approval of biosimilars in the EU.
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References
1. Derbyshire M. Patent expiry dates for biologicals: 2018 update. Generics and Biosimilars Initiative Journal (GaBI Journal). 2019;8(1):24-31. doi:10.5639/gabij.2019.0801.003
2. GaBI Online - Generics and Biosimilars Initiative. ‘Similar biologics’ approved and marketed in India [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Nov 27]. Available from: www.gabionline.net/Biosimilars/General/Similar-biologics-approved-and-marketed-in-India
3. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Japan [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Nov 27] Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Japan
4. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Nov 27] Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Europe
5. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Australia [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Nov 27] Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Australia
6. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in the US [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Nov 27]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-the-US
7. GaBI Online - Generics and Biosimilars Initiative. Insulin glargine biosimilars launched in UK and South Korea [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Nov 27]. Available from: www.gabionline.net/Biosimilars/News/Insulin-glargine-biosimilars-launched-in-UK-and-South-Korea
8. GaBI Online - Generics and Biosimilars Initiative. Biocon/Mylan launch first insulin glargine biosimilar in Australia [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Nov 27]. Available from: www.gabionline.net/Biosimilars/News/Biocon-Mylan-launch-first-insulin-glargine-biosimilar-in-Australia
9. GaBI Online - Generics and Biosimilars Initiative. Insulin glargine biosimilar gains South Korean approval [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Nov 27]. Available from: www.gabionline.net/Biosimilars/News/Insulin-glargine-biosimilar-gains-South-Korean-approval
10. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in South Korea [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Nov 27]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-South-Korea
11. GaBI Online - Generics and Biosimilars Initiative. Basal analogue insulin ‘copy biological’ launched in Indonesia [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Nov 27]. Available from: www.gabionline.net/Biosimilars/News/Basal-analogue-insulin-copy-biological-launched-in-Indonesia
12. GaBI Online - Generics and Biosimilars Initiative. Merck gains US infliximab contract but drops insulin glargine biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Nov 27]. Available from: www.gabionline.net/Biosimilars/General/Merck-gains-US-infliximab-contract-but-drops-insulin-glargine-biosimilar
13. GaBI Online - Generics and Biosimilars Initiative. FDA accepts application for Merck’s insulin glargine biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Nov 27]. Available from: www.gabionline.net/Biosimilars/News/FDA-accepts-application-for-Merck-s-follow-on-insulin-glargine
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