FDA approves biosimilar Truxima to treat three indications of Rituxan.- Celltrion + Teva

Celltrion, Inc.and Teva Pharmaceutical Industries Ltd. announced that the FDA has approved Truxima (rituximab-abbs), a monoclonal antibody (mAb) biosimilar to Rituxan (rituximab) for the treatment of adult patients in three indications: Relapsed or refractory, low-grade or follicular, CD20-positive, B-cell non-Hodgkin's lymphoma (NHL) as a single agent. Previously untreated follicular, CD20-positive, B-cell NHL in combination with first line chemotherapy and, in patients achieving a complete or partial response to a rituximab product in combination with chemotherapy, as single-agent maintenance therapy. Non-progressing (including stable disease), low-grade, CD20-positive, B-cell NHL as a single agent after first-line cyclophosphamide, vincristine, and prednisone (CVP) chemotherapy.

The FDA approval is based on a review of a comprehensive data package inclusive of foundational and extensive analytical characterization, nonclinical data, clinical pharmacology, immunogenicity, clinical efficacy, and safety data. The totality of evidence submitted for Truxima demonstrated that there were no clinically meaningful differences in purity, potency and safety between Truxima and Rituxan for the three indications.