Biocon, Mylan get approval for glargine insulin in Europe, Australia

Pharmaceutical manufacturer Biocon and its partner Mylan received marketing approval for their glargine insulin product Semglee in European Union and Australia, marking the first biosimilar approval for the partnership in Europe.

Biosimilars are drugs that mimic or imitate the actions of natural proteins or enzymes in the body, such as insulin.

Glargine insulin, which is available from a wide range of manufacturers, is a long-acting insulin analogue used to control blood sugar levels in those with diabetes.

However, unlike regular insulin that is often taken three times a day, glargine insulin needs to be taken only once a day and doesn’t result in steep fluctuations in sugar levels seen with regular insulin injections.

The product consists of microcrystals that slowly release insulin, giving a long duration of action of 18 to 26 hours, with a “peakless” profile.

The companies said Semglee has also been submitted in Canada. “Several submissions are planned for key emerging markets,” it added.

According to the partnership agreement between the two companies, Mylan has exclusive commercialization rights for insulin glargine in the U.S., Canada, Australia, New Zealand, the European Union and European Free Trade Association countries.

Biocon has exclusive rights for Japan and a few emerging markets, and co-exclusive commercialization rights with Mylan in the rest of the world.

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 EU approval of Semglee applies to all 28 member states and the European Economic Area (EEA) member states of Norway, lceiand and Liechtenstein, the companies said.