Posted by Michael Wonder on 28 Mar 2018
Mylan and Biocon receive approvals from the European Commission and TGA Australia for Semglee, biosimilar insulin glargine
27 March 2018 - Mylan and Biocon today announced that their co-developed biosimilar insulin glargine Semglee has received marketing authorisation approval from the European Commission following the positive recommendation by the CHMP of the EMA.
Semglee 100 units/mL 3 mL pre-filled 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, Australia has also approved biosimilar insulin glargine Semglee 100 IU/mL 3 mL pre-filled pen for the people with diabetes in Australia.
