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Sandoz Confirms US Natalizumab Delay Amid Push For Virus Test

FDA-Approved Tyruko, Developed By Polpharma, Already Launched In Europe

Executive Summary

Sandoz’s partnership with Polpharma to bring a US biosimilar to Tysabri to the US would make it “ultimately the closest I will ever get to an originator launch in my career,” according to Sandoz CEO Richard Francis. However, the launch has hit a roadblock in the form of a necessary assay approval for a virus that can trigger a potentially life-threatening brain disease.

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