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Biosimilars of insulin glargine Posted 08/04/2016

Last update: 7 April 2017

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.

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/-

Similar biologic’ launched in India in 2009 [1]. Received Japanese approval in March 2016 [2] and launched in July 2016. Submitted to EMA for approval in November 2016 [3]

Eli Lilly/Boehringer Ingelheim, US/Germany

Abasaglar/ Basaglar/ LY2963016

Approved by EMA in September 2014 [4], by US FDA in August 2014 [5], by Japan in January 2015 [6] and by Australia in May 2015 [7]

Kalbe Pharma, Indonesia*

-

Launched in Indonesia March 2017 [8]

Samsung Bioepis/Merck (MSD), South Korea/USA [9]

SB9/MK-1293

Submitted to FDA for approval in August 2016 and to EMA in December 2015 [9]. Approved by EMA in November 2016 [10]

Wockhardt, India*

Glaritus

‘Similar biologic’ launched in India in March 2009 [1]

EMA: European Medicines Agency; FDA: US Food and Drug Administration. 
*See editor’s comment.

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 [4]. 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 [10].

Editor’s comment
It should be noted that ‘similar biologics’ and ‘copy biologicals’ approved in India and Indonesia might not have been authorized following as strict a regulatory process as is required for approval of biosimilars in the European Union. The EMA (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.

Related Article
Biosimilar insulin launched in UK

References
1. GaBI Online - Generics and Biosimilars Initiative. Biologicals patent expiries [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Apr 8]. Available from: www.gabionline.net/Biosimilars/General/Biologicals-patent-expiries
2. GaBI Online - Generics and Biosimilars Initiative. Biocon receives Japanese approval for insulin glargine biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Apr 8] Available from: www.gabionline.net/Biosimilars/News/Biocon-receives-Japanese-approval-for-insulin-glargine-biosimilar
3. 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 2016 Nov 15]. Available from: www.gabionline.net/Biosimilars/News/Mylan-and-Biocon-submit-insulin-glargine-biosimilar-to-EMA  
4. GaBI Online - Generics and Biosimilars Initiative. European approval for biosimilar insulin [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Apr 8]. Available from: www.gabionline.net/Biosimilars/News/European-approval-for-biosimilar-insulin
5. GaBI Online - Generics and Biosimilars Initiative. FDA grants tentative approval for insulin treatment [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Apr 8]. Available from: www.gabionline.net/Biosimilars/News/FDA-grants-tentative-approval-for-insulin-treatment
6. GaBI Online - Generics and Biosimilars Initiative. Japanese approval for insulin glargine biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Apr 8]. Available from: www.gabionline.net/Biosimilars/News/Japanese-approval-for-insulin-glargine-biosimilar
7. GaBI Online - Generics and Biosimilars Initiative. Australian approval for biosimilar insulin [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Apr 8]. Available from: www.gabionline.net/Biosimilars/News/Australian-approval-for-biosimilar-insulin
8. GaBI Online - Generics and Biosimilars Initiative. Merck outlines biosimilars programme [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Nov 15]. Available from: www.gabionline.net/Biosimilars/News/Merck-outlines-biosimilars-programme
9. 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 2016 Sep 2]. Available from: www.gabionline.net/Biosimilars/News/FDA-accepts-application-for-Merck-s-follow-on-insulin-glargine
10. GaBI Online - Generics and Biosimilars Initiative. EMA approves biosimilars of insulin glargine and teriparatide [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Nov 15]. Available from: www.gabionline.net/Biosimilars/News/EMA-approves-biosimilars-of-insulin-glargine-and-teriparatide 

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Source: EMA, US FDA

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