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Biotechnology firm Biocon on Monday said its subsidiary Biocon Biologics and Mylan had 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 their product ‘Kixelle’ use for the treatment of type 1 and 2 diabetes.
“Biocon Biologics 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,” Biocon said in a regulatory filing.
Biocon said the CHMP positive opinion will be considered by the European Commission. The European Commission decision on approval is expected early next year.
Christiane Hamacher, CEO, Biocon Biologics, said the company will 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“.
Shares of Biocon were trading 0.58 per cent lower at ₹452.25 apiece on BSE.
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