Biocon Biologics and Mylan Receive CHMP Recommendation for Approval of Biosimilar Insulin Aspart

NOTIFICATION TO STOCK EXCHANGE

COMPANY STATEMENT

Bengaluru, Karnataka, India, Dec 14, 2020 –

This is to inform you that 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 authorization 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.

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.”