On September 10th 2014, the European Commission granted marketing authorisation for an insulin glargine, indicated to treat diabetes in adults, adolescents and children from the age of 2 years. This was the first insulin to be approved through the European Medicines Agency’s biosimilar pathway and followed ‘tentative approval’ for the same product from the Food and Drug Administration. The ‘tentative’ approval is the result of a patent infringement lawsuit in the US and anticipated delays almost certainly mean that Europe (and possibly the UK) will see the first launch.

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