Biocon Biologics, a subsidiary of Biocon, has announced that Kixelle, a biosimilar Insulin Aspart co-developed with Viatris, has received marketing authorisation approval from the European Commission 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.
“The European Commission’s approval of our biosimilar Insulin Aspart is an endorsement of the quality of our product and the data generated during its development. The approval will enable affordable access to a rapid-acting insulin analog for people with diabetes in the EU, where our biosimilar Insulin Glargine, a long-acting insulin analog, is already addressing patients’ needs for an affordable quality treatment option. We are leveraging our science, expertise and global scale manufacturing to expand access to our high quality, affordable biologics, globally.”