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The European approval marks the first approval for a biosimilar in that region resulting from the companies’ joint portfolio.
Mylan and Biocon have received marketing authorization approval from the European Commission (EC) for Semglee 100 units/mL 3-mL prefilled disposable pen, a biosimilar insulin glargine for treating diabetes, the companies announced on Mar. 27, 2018. Semglee is the first biosimilar resulting from Biocon and Mylan's joint portfolio to be approved in Europe. In addition, the companies received approval for the product in Australia from the Therapeutic Goods Administration (TGA).
"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 investments that we have made to develop and manufacture a leading portfolio of complex products, including Semglee, is one way that we are delivering on our commitment to expand access to high quality medicine," said Mylan President Rajiv Malik in a company press release.
"The approval of Mylan and Biocon's biosimilar insulin glargine by the European Commission and TGA Australia are important milestones in our collaboration. It furthers our mission to provide a high quality, affordable insulin analog for people with diabetes globally. As a credible, global insulins player, we are committed to address the growing healthcare challenges associated with diabetes and have made significant investments in R&D and manufacturing to build scale and make our affordable insulins portfolio available in many markets," added Dr. Arun Chandavarkar, CEO and joint managing director, Biocon.
The EC approval applies to all 28 European Union (EU) member states and the European Economic Area (EEA) member states of Norway, Iceland, and Liechtenstein. In addition, Mylan plans to launch Semglee in Australia later in 2018 and expects to begin launching the product across various markets in Europe in the second half of 2018. The companies have also filed marketing applications in Canada and the United States and plan to file in key emerging markets.
Biocon and Mylan are exclusive partners on a broad portfolio of biosimilars and insulin analogs. Glargine is one of the three insulin analogs being co-developed by the partners for the global marketplace. Mylan has exclusive commercialization rights for insulin glargine in the US, Canada, Australia, New Zealand, and the EU and EEA 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.