Semglee, an insulin glargine biosimilar, has EU and Australian approval to treat diabetes.- Mylan + Biocon.
-Mylan N.V. and Biocon Ltd. announced that their co-deveoped biosimilar insulin glargine Semglee has received marketing authorization approval from the European Commission (EC) 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.
Mylan plans to launch Semglee in Australia later this year and expects to begin launching the product across various markets in Europe in the second half of 2018.
Learning Zones
The Learning Zones are an educational resource for healthcare professionals that provide medical information on the epidemiology, pathophysiology and burden of disease, as well as diagnostic techniques and treatment regimens.
2 mins