The European Commission (EC) has granted marketing authorization for the insulin aspart biosimilar Kixelle (MYL 1601D), developed by US-based drugmaker Mylan (now Viatris) and India-based biologicals specialist Biocon.
Kixelle is a proposed biosimilar to Novo Nordisk’s NovoLog/NovoRapid/NovoMix (insulin aspart). Novo Nordisk reported estimated sales of Euros 1.8 billion (DKK 1.4 billion) globally for NovoRapid in 2019 . NovoLog/NovoRapid/NovoMix no longer has effective exclusivity through patent protection or data protection in either Europe or the US .
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 approval by the EC on 5 February 2021 follows the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) positive recommendation during its meeting, which took place on 7–10 December 2020. The CHMP recommended at that meeting that Kixelle be approved for the treatment of diabetes mellitus.
Kixelle is the second insulin aspart biosimilar to receive approval in the EU. Insulin aspart Sanofi received marketing approval in Europe on 25 June 2020 . The centralized marketing authorization granted by the EC is valid in all European Union Member States as well as in the European Economic Area (EEA) countries Iceland, Liechtenstein and Norway.
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 .
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) .
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 .
Biosimilars of insulin aspart
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