Sanofi Files First Biosimilar Insulin Aspart In Challenge To NovoRapid
Executive SummaryThe European Medicines Agency is evaluating Sanofi's SAR341402, the first biosimilar insulin aspart product to be submitted for EU marketing authorization. If approved, the product will compete with Novo Nordisk's diabetes drug Novorapid/NovoLog.
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A list of new EU biosimilar product filings, CHMP opinions and marketing authorizations issued by the European Commission. The updated list includes the filing of the first biosimilar version of insulin aspart and the approval of the EU’s sixth biosimilar pegfilgrastim product.
The Conservative Party's victory in the UK general election means the Brexit withdrawal deal will be able to pass. The UK will leave the EU by 31 January and enter a transition period during which medicines regulation will remain broadly unchanged.