The European Medicines Agency decided that, in accordance with EU requirements for biosimilar medicines, Insulin aspart Sanofi has a highly similar structure, purity and biological activity to NovoRapid and is distributed in the body in the same way. In addition, studies in patients with diabetes have shown that the safety and effectiveness of Insulin aspart Sanofi is equivalent to that of NovoRapid.

All these data were considered sufficient to conclude that Insulin aspart Sanofi will behave in the same way as NovoRapid in terms of effectiveness and safety in its authorised uses. Therefore, the Agency’s view was that, as for NovoRapid, the benefits of Insulin aspart Sanofi outweigh the identified risks and it can be authorised for use in the EU.