US FDA accepts Sandoz’s proposed biosimilar of rituximab for review

Sandoz, a Novartis Division, and the pioneer and global leader in biosimilars, announced that the US Food and Drug Administration (FDA) has accepted Biosimilar application under the 351 (k) pathway for a proposed biosimilar to the reference medicine, Rituxan (rituximab).

The BLA consists of a comprehensive data package that includes analytical, preclinical and clinical data. Clinical studies included a pharmacokinetic/pharmacodynamic (PK/PD) trial in rheumatoid arthritis (ASSIST-RA), and a Phase III confirmatory safety and efficacy study in follicular lymphoma (ASSIST-FL).

Sandoz believes these data provide confirmation that the proposed biosimilar matches the reference medicine in terms of safety, efficacy and quality.