Biocon Ltd, the biotechnology major said the European Medicines Agency (EMA) has accepted its request for the review of its partner Mylan's marketing authorization application (MAA) for insulin glargine which is used to treat adults with type 2 diabetes. Mylan and Biocon, have collectively co-developed insulin glargine and are looking forward to offering another insulin treatment option for diabetic patients, who are often facing significant expense to manage their disease, Biocon declared in a regulatory filing.
According to Mylan’s President Rajiv Malik the acceptance of the regulatory submission for insulin glargine in Europe is another example of the strong progress the Company continues to make across the exciting portfolio of complex products the Company has have in development, and is another demonstration of the success of our partnership with Biocon.
There is a significant unmet need around the world for more affordable versions of injectable insulin products, he further added. The company is looking forward to helping serve this patient population, building on our existing strength in oral diabetic drugs, by bringing this product to the European market and other markets around the world upon approval.
Biocon CEO and Joint MD Arun Chandavarkar said the acceptance of the insulin glargine application for review by EMA is another important milestone in Biocon's collaboration with Mylan.
He also said that this is the third filing from our portfolio comprising biosimilar monoclonal antibodies, insulin analogs and other recombinant proteins to be accepted by EMA in the year 2016. Importantly, this is the first filing in a developed market.
Biocon and Mylan are exclusive partners on a broad portfolio of biosimilars and insulin analogs too. Glargine is one of the three insulin analogs which are being co-developed by the two entities for the global marketplace.
Mylan has exclusive commercialization rights for insulin glargine in the US, Canada, Australia, New Zealand, the European Union along with European Free Trade Association countries. Biocon has exclusive rights for Japan as well as a few emerging markets and also has co-exclusive commercialization rights with Mylan in the rest of the world.
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