Bengaluru, February 12 Biocon Biologics Ltd, a subsidiary of Biocon Ltd, has got marketing authorisation approval from the European Commission for Kixelle - a biosimilar Insulin Aspart co-developed with Viatris Inc.
The approval has come following the positive recommendation by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency.
The company, in a regulatory filing to the exchanges, said 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 a vial and pre-filled pen presentations.
The EC’s centralised marketing authorisation is valid in all EU Member States and in the European Economic Area (EEA) countries Iceland, Liechtenstein and Norway.
The company spokesperson for Biocon Biologics said “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.”