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Biocon has received marketing authorization from the European Commission.
Mylan N. V. and Biocon declared that their co-developed biosimilar insulin glargine Semglee, has received marketing authorization approval from the European Commission, following the positive recommendation by the committee of Medicinal products for Human use 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 which is approved in Europe.
Furthermore, the Therapeutic Goods Administration (TGA), Australia has also given approval to biosimilar insulin Glargine Semglee 100 IU/mL 3 mL prefilled pen for people with diabetes in Australia.
