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EMA to review Biocon-Mylan’s version of Glargine insulin

04 Nov 2016 Evaluate

The European Medicines Agency (EMA) has accepted for review Mylan’s Marketing Authorization Application (MAA) for insulin Glargine, which has been co-developed by Mylan and Biocon. Glargine is a long-acting insulin analog used to treat adults with type 2 diabetes and adults and pediatric patients (children 6 years and older) with type 1 diabetes for the control of high blood sugar.

This filing includes analytical, functional and pre-clinical data, as well as results from the pharmacokinetics (PK) and confirmatory efficacy/safety global clinical trial in Type 2 diabetes patients comparing Mylan’s and Biocon’s Insulin glargine with Lantus.

Biocon is India’s largest and Asia’s leading Biotechnology Company with a strategic focus on biopharmaceuticals and research services. It is a fully integrated, innovation-driven biopharma enterprise offering affordable solutions for chronic diseases to patient's worldwide.



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