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

Bengaluru, Feb 12 (PTI)Biocon Biologics Ltd.,asubsidiary ofBengaluru-headquartered Biocon Ltd.,hasannounced thatKixelle, a biosimilar insulin aspartco-developed with NASDAQ-listed Viatris Inc., has receivedmarketing authorisation approval from the European Commission.

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

''Kixelle,a fast-acting insulin analog indicatedfor the treatment of diabetes mellitus in adults, adolescentsand children aged one year and above, has been approved as a100 units/ml solution for injection in vial and pre-filled penpresentations,'' it said.

The centralised marketing authorisation granted bythe EC is valid in all EU Member States as well as in theEuropean Economic Area countries Iceland, Liechtenstein andNorway, the statement said.PTI RS BNADMINISTRATOR BNADMINISTRATOR

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