Mylan and Biocon receive approval for Semglee Biosimilar Insulin Glargine

From European Commission and TGA, Australia

Mylan and Biocon announced that their co-developed biosimilar insulin glargine Semglee has received marketing authorisation approval from the European Commission following the positive recommendations by the Committee for Medicinal Products for Human Use (CHMP) of European Medicines Agency.

Semglee 100units/mL 3mL 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 100units/mL 3mL prefilled disposable pen for people with diabetes in Australia.

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