Last update: 27 August 2021
Insulin aspart is a type of manufactured insulin used to treat type 1 and type 2 diabetes. It has a more rapid onset and a shorter duration of activity than normal human insulins.
The originator product, Novo Nordisk’s NovoLog (insulin aspart), was approved by the US Food and Drug Administration (FDA) in June 2000 and NovoRapid/NovoMix were approved in Europe in September 1999 and August 2000, respectively [1]. Novo Nordisk reported estimated sales of Euros 1.8 billion (DKK 1.4 billion) globally for NovoRapid in 2019, making insulin aspart a lucrative target for biosimilars.
NovoLog/NovoRapid/NovoMix no longer have effective exclusivity through patent protection or data protection in either Europe or the US. Some of the insulin aspart biosimilars and non-originator biologicals approved or in development are presented in Table 1.
| Table 1: Biosimilars and non-originator biologicals* of insulin aspart approved or in development
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| Company name, Country
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Product name
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Stage of development
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| Biocon/Viatris (Mylan), India*/USA
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Kixelle (MYL‑1601D)
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Approved in Europe in February 2021 [2]. ‘On track’ for 2nd quarter 2020 submission to FDA [3].
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| Sanofi, USA
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Insulin aspart Sanofi (EU)/ Truvelog (Australia)/ Trurapi (Canada)
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Approved by EMA in April 2020 [4] and EC in June 2020 [5]. Approved by Australia’s TGA in October 2020 [6]. Approved by Health Canada in October 2020 [7]
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| 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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Sanofi’s insulin aspart biosimilar was approved by the EMA’s Committee for Medicinal Products for Human Use (CHMP) on 30 April 2020 [4] and by the European Commission (EC) on 25 June 2020 [5]. Truvelog was approved by Australia’s Therapeutic Goods Administration (TGA) on 23 October 2020 [6].
Kixelle was recommended for approval by EMA’s Committee for Medicinal Products for Human Use on 10 December 2020 [2]. Mylan also mentioned in its quarterly earnings call that it was ‘on track’ for the US submission of its insulin aspart biosimilar in the second quarter of 2020 [3].
Generics giant Mylan (now Viatris) and India-based Biocon made an agreement back in February 2013 to develop and market Biocon’s biosimilar versions of three insulin analogue products, which include Sanofi’s Lantus (insulin glargine), Eli Lilly’s Humalog (insulin lispro) and Novo Nordisk’s NovoLog (insulin aspart) [8].
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 ‘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.
Related article
Biosimilars of insulin lispro
Biosimilars of insulin glargine
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References
1. Derbyshire M. Patent expiry dates for biologicals: 2017 update. Generics and Biosimilars Initiative Journal (GaBI Journal). 2018;7(1): 29-34. doi:10.5639/gabij.2018.0701.007
2. GaBI Online - Generics and Biosimilars Initiative. EC approval for insulin aspart biosimilar Kixelle [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Aug 27]. Available from: www.gabionline.net/biosimilars/news/EC-approval-for-insulin-aspart-biosimilar-Kixelle
3. GaBI Online - Generics and Biosimilars Initiative. FDA accepts application for Mylan’s bevacizumab biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Aug 27]. Available from: www.gabionline.net/Biosimilars/News/FDA-accepts-application-for-Mylan-s-bevacizumab-biosimilar
4. GaBI Online - Generics and Biosimilars Initiative. EMA recommends approval of Sanofi’s insulin aspart biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Aug 27]. Available from: www.gabionline.net/Biosimilars/News/EMA-recommends-approval-of-Sanofi-s-insulin-aspart-biosimilar
5. GaBI Online - Generics and Biosimilars Initiative. EC approval for Sanofi’s insulin aspart biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Aug 27]. Available from: www.gabionline.net/Biosimilars/News/EC-approval-for-Sanofi-s-insulin-aspart-biosimilar
6. GaBI Online - Generics and Biosimilars Initiative. Australia approves etanercept and insulin aspart biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Aug 27]. Available from: www.gabionline.net/Biosimilars/News/Australia-approves-etanercept-and-insulin-aspart-biosimilars
7. GaBI Online - Generics and Biosimilars Initiative. Canada approves insulin aspart biosimilar Trurapi [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Aug 27]. Available from: www.gabionline.net/Biosimilars/News/Canada-approves-insulin-aspart-biosimilar-Trurapi
8. GaBI Online - Generics and Biosimilars Initiative. Mylan and Biocon to partner on insulin products [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Aug 27]. Available from: www.gabionline.net/Biosimilars/News/Mylan-and-Biocon-to-partner-on-insulin-products
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Source: EMA, Novo Nordisk, US FDA
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