Mylan, Biocon Get Approval For Glargine Insulin In Europe, Australia

(RTTNews) - Mylan N.V. (MYL) and Biocon Ltd. (BIOCON, 532523) announced that their co-developed 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.

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.

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.

The company specified that 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.

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.

In addition to these approvals, marketing applications for Semglee have been submitted in Canada and the U.S., and are planned for key Emerging Markets.