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# FDA Rejects Sandoz Biosimilar Rituximab
- URL: https://www.fdaweb.com/fda-rejects-sandoz-biosimilar-rituximab/
- Published: 2018-05-03T12:00:00.000Z
- Updated: 2026-09-15T00:02:32.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5141359

FDA has issued a complete response letter to Sandoz for its BLA for a biosimilar of rituximab (Genentech’s Rituxan), indicated for treating some non-Hodgkin’s lymphomas. The company [says](http://www.marketwatch.com/story/sandoz-receives-complete-response-letter-from-the-us-fda-for-proposed-biosimilar-rituximab-2018-05-02?ref=fdaweb.com) it 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.”