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Biocon on Wednesday 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, 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 biosimilar insulin glargine Semglee 100 IU/mL 3 mL prefilled pen for the 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.
Mylan President Rajiv Malik said that this biosimilar which has been introduced in Europe and Australia would help people with diabetes.
According to Arun Chandavarkar, CEO and Joint Managing Director, Biocon, the approval of Mylan and Biocon’s biosimilar insulin glargine by the European Commission and TGA Australia are important milestones.
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.
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