Biocon Biologics, Viatris get EC nod to Biosimilar Insulin Aspart Kixelle
Bengaluru: Biocon Biologics Ltd., a subsidiary of Biocon Ltd., has announced that Kixelle, a biosimilar Insulin Aspart co-developed with Viatris Inc., 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 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 European Commission's approval of our biosimilar Insulin Aspart is an endorsement of the quality of our product and the data generated during its development. 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. We are leveraging our science, expertise and global scale manufacturing to expand access to our high quality, affordable biologics, globally.," the company said in a statement.
Biocon Limited is an innovation-led global biopharmaceuticals company committed to enhance affordable access to complex therapies for chronic conditions like diabetes, cancer and autoimmune diseases.
The company 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.