EMA recommends approval of insulin aspart biosimilar Kixelle

Biosimilars/News | Posted 29/01/2021 post-comment0 Post your comment

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced on 11 December 2020 that it had recommended granting of marketing authorization for an insulin aspart biosimilar.

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The insulin aspart biosimilar, which will be called Kixelle, has been developed by US-based drugmaker Mylan (now Viatris) and Indian biologicals specialist Biocon.

The drug is a biosimilar of Novo Nordisk’s NovoLog (insulin aspart). 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 insulin. The positive opinion from EMA’s CHMP recommends the use of Kixelle for the treatment of diabetes mellitus.

Christiane Hamacher, CEO of Biocon, said ‘we are extremely pleased to receive a positive opinion from the EMA’s CHMP for our biosimilar insulin aspart, co developed with Mylan. This is an endorsement of the quality of our product and the data generated during its development’.

The CHMP positive opinion will now be considered by the European Commission (EC). Once approved the EC will grant a centralized marketing authorization for member countries of the European Union (EU). Biocon expects the decision on the EC’s approval early in 2021.

Assuming it receives final EU approval, Kixelle will be the second insulin aspart biosimilar to receive approval in the EU. Insulin aspart Sanofi received marketing approval in Europe on 25 June 2020 [1].

According to EMA’s list of applications for new human medicines under evaluation by the CHMP released on 15 January 2020, the agency is reviewing a third insulin aspart biosimilar [2].

Mylan and Biocon made an agreement back in February 2013 to develop and market Biocon’s biosimilar versions of three insulin analogue products, which included versions of Sanofi’s Lantus (insulin glargine), Eli Lilly’s Humalog (insulin lispro) and Novo Nordisk’s NovoLog (insulin aspart) [3].

Mylan also mentioned in its quarterly earnings call that it was ‘on track’ for its US submission in the second quarter of 2020 for its insulin aspart biosimilar [4].

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1. 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 Jan 29]. Available from: www.gabionline.net/Biosimilars/News/EC-approval-for-Sanofi-s-insulin-aspart-biosimilar 
2. GaBI Online - Generics and Biosimilars Initiative. Biosimilar applications under review by EMA – January 2021 [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Jan 29]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-applications-under-review-by-EMA-January-2021 
3. 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 Jan 29]. Available from: www.gabionline.net/Biosimilars/News/Mylan-and-Biocon-to-partner-on-insulin-products 
4. 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 Jan 29]. Available from: www.gabionline.net/Biosimilars/News/FDA-accepts-application-for-Mylan-s-bevacizumab-biosimilar

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Source: EMA, Sanofi

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