Mylan, Biocon Get EC, TGA Australia Nod For Biosimilar Insulin Glargine Semglee

(RTTNews) - Mylan N.V. (MYL) and India-based biopharmaceutical company Biocon Ltd. said that their co-developed biosimilar insulin glargine Semglee has received marketing authorization approval from the European Commission or 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.

In addition, the Therapeutic Goods Administration or TGA of Australia has also approved biosimilar insulin glargine Semglee 100 IU/mL 3 mL prefilled pen for the people with diabetes in Australia.

Mylan President Rajiv Malik said, "We are excited to be able to bring Mylan and Biocon's biosimilar insulin glargine to Europe and Australia where millions of people are currently living with diabetes, and we are committed to continuing to bring high quality, more affordable biosimilar products to markets around the world."

The EC approval of Semglee applies to all 28 European Union or EU member states and the European Economic Area or EEA member states of Norway, Iceland and Liechtenstein.

Diabetes is the fastest growing chronic condition in the world and the prevalence of this disease is increasing among all ages. In Europe, the number of diabetics are expected to grow to 38 million by 2030, while in Australia it currently affects nearly two million people.

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.