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EU Biosimilar Filings, Opinions And Approvals

Executive Summary

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.

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Sanofi Files First Biosimilar Insulin Aspart In Challenge To NovoRapid

The 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.

2019 Sees Decline In EMA Drug Approval Recommendations

The number of positive opinions given by the EMA’s CHMP has fallen to 66 this year from 84 in 2018.

UK Set For January Brexit After Conservatives Win Election

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.

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