(CercleFinance.com) – Sandoz, the generics and biosimilars division of Novartis in the process of being spun off, announces that the United States FDA has approved the biosimilar Tyruko (natalizumab-sztn), developed by its partner Polpharma Biologics.
Tyruko is approved to treat all indications covered by the reference drug and is the first and only FDA-approved biosimilar for relapsing forms of multiple sclerosis (MS).
“Tyruko has the potential to expand the reach of natalizumab treatment for patients, increase healthcare cost savings and drive innovation through competition,” said Keren Haruvi, president North America of Sandoz.
The FDA granted the approval based on a set of analytical, functional and clinical data. It comes with labeling with safety warnings and a risk assessment and mitigation strategy.
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