EU approves Kixelle for type 2 diabetes.- Biocon Biologics

Biocon Biologics Ltd., a subsidiary of Biocon has announced that Kixelle, a biosimilar Insulin Aspart co-developed with Viatris Inc. (NASDAQ: VTRS), has received marketing authorization 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 active substance of Kixelle is insulin aspart, a fast-acting insulin analogue (ATC code: A10AB05) which is absorbed more rapidly by the body and can therefore act faster than human insulin. The replacement insulin acts in the same way as naturally produced insulin; it works by facilitating uptake of glucose into skeletal muscle and fat tissue, and by inhibiting glucose output from the liver. Kixelle is a biosimilar medicinal product. It is highly similar to the reference product NovoRapid (insulin aspart), which was authorised in the EU on 7 September 1999.