FDA Sends Sandoz Complete Response Letter for Rituximab

Sandoz, a division of Novartis, received a complete response letter for its proposed biosimilar, rituximab, a drug used to treat certain types of cancers and autoimmune diseases.

The drug, which already earned approval in Europe, was seeking FDA approval for treating non-Hodgkin’s lymphoma, chronic lymphocytic leukemia and immunological diseases like rheumatoid arthritis.

“Sandoz stands behind the robust body of evidence included in the regulatory submission and is currently evaluating the content of the letter,” the company said. “While disappointed, Sandoz remains committed to further discussions with FDA in order to bring this important medicine to US patients as soon as possible.”