Sandoz announced last week that the FDA issued a complete response letter for its proposed biosimilar to rituximab. In the announcement, Sandoz stated that it “stands behind the robust body of evidence included in the regulatory submission and is currently evaluating the content of the letter.” Sandoz further indicated that although disappointed, it “remains committed to further discussions with the FDA to bring this important medicine to US patients as soon as possible.”
Sandoz initially announced that the FDA accepted its application for its proposed rituximab biosimilar on September 12, 2017. Sandoz’s licensing application to the United States FDA followed the approval of its rituximab biosimilar for all indications in Europe.
Rituximab is an anti-CD20 monoclonal antibody approved for the treatment of non-Hodgkin’s lymphoma (follicular lymphoma and diffuse large B-cell lymphoma) and chronic lymphocytic leukemia, as well as immunological diseases such as rheumatoid arthritis, granulomatosis with polyangiitis, and microscopic polyangiitis.
We will continue to keep you updated on further developments.