EU, Australia Clear Biocon-Mylan Biosimilar Insulin Glargine

Bengaluru-based biotech firm, Biocon, said that its co-developed biosimilar insulin glargine Semglee has received marketing approval from the European Commission. Biocon has developed this biosimilar with Mylan. Semglee 100 units/ml 3 ml is a pre-filled disposable pen for people with diabetes and is the first biosimilar from two companies’ joint portfolio that has received approval in Europe, according to a company statement.

Additionally, the Therapeutic Goods Administration (TGA), an Australian regulatory body has also approved the biosimilar for people with diabetes in Australia. Following the approval, 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.

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. In addition to these approvals, marketing applications for Semglee have also been submitted in Canada and the US. Several submissions are planned for key emerging markets, the company informed.