Sanofi Is First To File Biosimilar Insulin Aspart
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.
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Sanofi has received formal approval from the European Commission for its insulin aspart biosimilar.
Sanofi has received a positive opinion from the CHMP for its insulin aspart biosimilar rival to NovoRapid. Meanwhile, Accord and Janssen-Cilag have also received positive opinions for generics and hybrid medicines.
Pharmaceutical companies in the UK have again been asked to ensure they have contingency measures in place to deal with potential supply problems at channel ports – this time in preparation for the UK’s formal departure from the EU’s single market and customs union at the beginning of 2021. The industry is continuing to push for a mutual recognition agreement on drug regulation.