Insulin aspart biosimilar gets EMA nod
medwireNews: A biosimilar of the rapid-acting insulin aspart has received a positive opinion from the EMA.
The biosimilar (insulin aspart Sanofi) is approved for use in adults and children aged at least 1 year with diabetes, based on the findings of the GEMELLI 1 trial.
The open-label GEMELLI 1 study involved 497 adults with type 1 diabetes and 100 with type 2 diabetes, who were randomly assigned to receive insulin aspart (NovoRapid/NovoLog) or the biosimilar. The biosimilar proved noninferior when used for a period of 6 months, and the two insulin analogs had similar safety profiles.
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