Indonesian generics maker Kalbe Pharma (Kalbe) announced on 25 March 2017 the launch of a basal analogue insulin ‘copy biological’ in Indonesia.
The product is a ‘copy biological’ of Sanofi’s Lantus (insulin glargine). 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 announcement of the launch was made during a symposium on the management of type-2 diabetes. According to Kalbe, the insulin ‘copy biological’ is the first product of its kind for type-2 diabetes mellitus sufferers in Indonesia.
Eli Lilly/Boehringer Ingelheim’s insulin glargine biosimilar, Abasaglar/Basaglar/LY2963016 was approved by the European Medicines Agency (EMA) in September 2014 [1], by US Food and Drug Administration (FDA) in August 2014 [2], by Japan in January 2015 [3], and by Australia in May 2015 [4]. Samsung Bioepis/Merck submitted their application for approval of their insulin glargine biosimilar (MK-1293/SB9) to FDA for approval in August 2016 and to EMA in December 2015 [5]. Biocon/Mylan submitted their application to EMA for approval of their insulin glargine biosimilar in November 2016 [6].
Editor’s comment
It should be noted that ‘copy biologicals’ approved in Indonesia might not have been authorized following as strict a regulatory process as is required for 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
Biosimilars of insulin glargine
References
1. GaBI Online - Generics and Biosimilars Initiative. European approval for biosimilar insulin [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Apr 7]. Available from: www.gabionline.net/Biosimilars/News/European-approval-for-biosimilar-insulin
2. GaBI Online - Generics and Biosimilars Initiative. FDA grants tentative approval for insulin treatment [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Apr 7]. Available from: www.gabionline.net/Biosimilars/News/FDA-grants-tentative-approval-for-insulin-treatment
3. GaBI Online - Generics and Biosimilars Initiative. Japanese approval for insulin glargine biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Apr 7]. Available from: www.gabionline.net/Biosimilars/News/Japanese-approval-for-insulin-glargine-biosimilar
4. GaBI Online - Generics and Biosimilars Initiative. Australian approval for biosimilar insulin [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Apr 7]. Available from: www.gabionline.net/Biosimilars/News/Australian-approval-for-biosimilar-insulin
5. 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 2017 Apr 7]. Available from: www.gabionline.net/Biosimilars/News/FDA-accepts-application-for-Merck-s-follow-on-insulin-glargine
6. 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 2017 Apr 7]. Available from: www.gabionline.net/Biosimilars/News/Mylan-and-Biocon-submit-insulin-glargine-biosimilar-to-EMA
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