Sanofi Files First Biosimilar Insulin Aspart In Challenge To NovoRapid
Executive Summary
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.
You may also be interested in...
EU Biosimilar Filings, Opinions And Approvals
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.
Industry & Regulators To Align Advice on COVID-19 Vaccine Updates
A multi-stakeholder workshop looked at the data needed to support updates to vaccine composition and the time required by manufacturers to update their vaccines, change their manufacturing processes and prepare approval applications.
Denmark Planning To Impose Drug Stockpiling Obligations From July
A new bill is intended to address the increase in medicine supply problems in Denmark in recent years.