Biocon Biologics, Viatris receive EC approval for biosimilar insulin aspart Kixelle

Biocon Biologics Ltd.,a subsidiary ofBengaluru-headquartered Biocon Ltd.,has announced thatKixelle, a biosimilar insulin aspart co-developed with NASDAQ-listed Viatris Inc., has received marketing authorisation approval from the European Commission.

This follows the positive recommendation by the Committee for Medicinal Products for Human Use of the European Medicines Agency, a Biocon statement said on Friday.

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

The centralised marketing authorisation granted by the EC is valid in all EU Member States as well as in the European Economic Area countries Iceland, Liechtenstein and Norway, the statement said.