Biocon Biologics (a subsidiary of Biocon), and Mylan (a subsidiary of Viatris) have received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommending approval of the market authorisation of Kixelle, a biosimilar insulin Aspart, which is rapid-acting insulin for the treatment of Type 1 and 2 diabetes.
The CHMP positive opinion will be considered by the European Commission. The European Commission decision on approval is expected early next year.
Dr Christiane Hamacher, CEO, Biocon Biologics, said, “We are extremely pleased to receive a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) for our biosimilar Insulin Aspart co-developed with Mylan. This is an endorsement of the quality of our product and the data generated during its development. We look forward to a final decision from the European Commission approving Insulin Aspart, which will enable us to expand our offering to people with diabetes to include a rapid-acting insulin analog along with a long-acting insulin glargine.”