ZURICH: 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.
“Sandoz stands behind the robust body of evidence included in the regulatory submission and is currently evaluating the content of the letter. While disappointed, Sandoz remains committed to further discussions with FDA in order to bring this important medicine to U.S. patients as soon as possible,” it said.
(Reporting by Michael Shields, editing by John Revill)