Biocon Biologics receives European Commission approval for Kixelle (biosimilar insulin aspart)

Biocon announced that its subsidiary, Biocon Biologics has received marketing authorization approval from European Commission for Kixelle, a biosimilar Insulin Aspart co-developed with Viatris Inc. following the positive recommendation by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency.

Kixelle, a fast-acting insulin analog indicated for the treatment of diabetes mellitus in adults, adolescents and children aged 1 year and above, has been approved as a 100 units/ml solution for injection in vial and pre-filled pen presentations.

The centralized marketing authorization granted by the EC is valid in all EU Member States as well as in the European Economic Area (EEA) countries Iceland, Liechtenstein and Norway.

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