Sandoz Gets Complete Response Letter From FDA For Proposed Biosimilar Rituximab

(RTTNews) - Sandoz, a Novartis division, Wednesday said that the US Food and Drug Administration has issued a complete response letter regarding the Biologics Licensing Application for its proposed biosimilar rituximab.

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

Sandoz has five biosimilar medicines currently marketed in various countries worldwide.