Sandoz, a Novartis division, have announced that the US Food and Drug Administration (FDA) has issued a complete response letter (CRL) regarding the Biologics Licensing Application (BLA) 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. While disappointed, Sandoz remains committed to further discussions with FDA in order to bring this important medicine to US patients as soon as possible.
There is a substantial unmet need for access to safe and effective therapies. Sandoz is committed to increasing patient access to high-quality, life-enhancing biosimilar medicines. As the pioneer and global leader in biosimilar medicines, Sandoz has five biosimilar medicines currently marketed in various countries worldwide, as well as a leading global pipeline.