Yesterday, Sandoz announced that the FDA has issued a Complete Response Letter (CRL) regarding its aBLA for its proposed biosimilar of Rituxan® (rituximab). Sandoz states that it “stands behind the evidence that it submitted to the FDA and that, “[w]hile disappointed, Sandoz remains committed to further discussions with FDA in order to bring this important medicine to US patients as soon as possible.”
Stay tuned to Big Molecule Watch for further developments.