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Novartis biosimilar cancer drug hits U.S. regulatory bump

May 3, 2018 5:24 AM
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ZURICH (Reuters) - Novartis AG said its biosimilar version of rituximab to treat blood cancers and immunological diseases such as rheumatoid arthritis had not won regulatory approval from the U.S. Food and Drug Administration (FDA).

The medicine made by Novartis’ Sandoz unit has been proposed as a biosimilar to MabThera/Rituxan by Roche and Biogen. Sandoz said it got only a so-called complete response letter from the FDA.

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