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Biocon And Viatris Scoop EU Insulin Aspart Approval

Analyst Expects Biosimilar Penetration To Be ‘Slow And Minimal’

 
• By Dean Rudge

Biocon and Viatris have landed their second biosimilar insulin approval in Europe, for a rival to Novo Nordisk’s NovoRapid (insulin aspart). Analyst reaction was lukewarm considering the “disappointing” launch of insulin glargine in Europe more than two years ago.

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Kixelle’s approval comes soon after Biocon announced the abrupt exit of Biocon Biologics’ CEO Christiane Hamacher • Source: Shutterstock

The European Commission has rubberstamped a recommendation for approval for the Kixelle (insulin aspart) biosimilar to Novo Nordisk’s NovoRapid, handing a significant marketing authorization to the newly-formed Viatris and its development partner Biocon.

“While management has not indicated specific launch timing of the approved Kixelle, we believe it will be commercialized during the first half of 2021 – Biocon previously indicated that it expects to launch during its

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