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Biocon Biologics Ltd (a subsidiary of Biocon Ltd) and Mylan (a subsidiary of Viatris Inc) 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 a 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 the approval is expected early next year,” the company said in a regulatory filing to exchanges.
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.”
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