European Commission expresses positive opinion on rapid-acting insulins of Biocon Biologics

A subsidiary of Biocon Limited i.e. Biocon Biologics and Mylan, a subsidiary of Viatris Inc., have received a positive opinion from 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 company awaits the final decision of European Commission to approve Insulin Aspart, which would enable Biocon to expand its offering to people with diabetes to include rapid-acting insulin analog along with a long-acting insulin glargine. The approval from European Commission is expected early next year.

Dr Christiane Hamacher, CEO of 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.”

Today, Biocon opened at Rs 459 per share, 1.1 per cent up from its previous close, with Rs 477.9 being the company's 52-week high and Rs 235.8 as its 52-week low.