Mylan N.V., one of the world’s leading pharmaceutical companies, and Biocon Ltd., Asia’s premier biopharmaceutical company, today announced that their co-developed biosimilar insulin glargine Semglee™ has received marketing authorization approval from the European Commission following the positive recommendation by the Committee for Medicinal Products for Human Use (CHMP) of European Medicines Agency. Semglee™ 100 units/mL 3 mL prefilled disposable pen for people with diabetes, is the first biosimilar from Biocon and Mylan’s joint portfolio to be approved in Europe.
Additionally, the Therapeutic Goods Administration (TGA), Australia has also approved biosimilar insulin glargine Semglee™ 100 IU/mL 3 mL prefilled pen for the people with diabetes in Australia.
Dr. Arun Chandavarkar, CEO and Joint Managing Director, Biocon, said, “The approval of Mylan and Biocon’s biosimilar insulin glargine by the European Commission and TGA Australia are important milestones in our collaboration. It furthers our mission to provide a high quality, affordable insulin analog for people with diabetes globally. As a credible, global insulins player, we are committed to addressing the growing healthcare challenges associated with diabetes and have made significant investments in R&D and manufacturing to build scale and make our affordable insulins portfolio available in many markets.”
The EC approval of Semglee™ applies to all 28 European Union (EU) member states and the European Economic Area (EEA) member states of Norway, Iceland and Liechtenstein.