Biocon's unit Biocon Biologics receives approval for Kixelle

Biocon Biologics, a subsidiary of Biocon has announced that Kixelle, a biosimilar Insulin Aspart co-developed with Viatris Inc, has received marketing authorization approval from the European Commission.

Biocon said that approval was received 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 centralized marketing authorization granted by the EC is valid in all EU Member States as well as in the European Economic Area (EEA) countries Iceland, Liechtenstein and Norway.

The approval will enable affordable access to a rapid acting insulin analog for people with diabetes in the EU, where our biosimilar Insulin Glargine, a long acting insulin analog, is already addressing patients' needs for an affordable quality treatment option, Biocon said. The announcement was made before market hours today, 12 February 2021.

Shares of Biocon rose 0.49% to Rs 410 on BSE. Biocon Biologics is leveraging its science, scale and expertise to shift the access paradigm for patients in need of biosimilars across the globe. The Biocon subsidiary is uniquely positioned as a fully integrated 'pure play' biosimilars organization in the world.

Biocon is an innovation-led global biopharmaceuticals company. It has developed and commercialized novel biologics, biosimilars, and complex small molecule APIs in India and several key global markets as well as generic formulations in the US and Europe.

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