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# Advisors Back Rituxan Biosimilar
- URL: https://www.fdaweb.com/advisors-back-rituxan-biosimilar/
- Published: 2018-10-10T12:00:00.000Z
- Updated: 2026-09-15T00:37:06.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5142559

Members of the FDA Oncologic Drugs Advisory Committee voted unanimously to recommend approval of Celltrion’s CT-P10, a proposed monoclonal antibody biosimilar to Biogen’s Rituxan (rituximab) for treating adult patients in three proposed indications. The company’s BLA seeks approval for these indications: **(1)** relapsed or refractory, low-grade or follicular, CD20-positive, B-cell Non-Hodgkin’s lymphoma (NHL) as a single agent; **(2)** 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; and **(3)** non-progressive (including stable disease), low-grade, CD20-positive, B-cell NHL as a single agent after first-line cyclophosphamide, vincristine, and prednisone chemotherapy.

The committee reportedly based its recommendation on a review of a comprehensive data package inclusive of foundational analytical biosimilarity data, nonclinical data, clinical pharmacology, immunogenicity and clinical efficacy and safety data.  
Celltrion says the results of the CT-P10 clinical development program demonstrated that there were no clinically meaningful differences between CT-P10 and Rituxan in terms of the safety, purity, and potency of the product for the three proposed indications.

Celltrion and Teva entered into a 10/2016 exclusive partnership to commercialize CT-P10 in the U.S. and Canada.