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# FDA Panel to Review Celltrion Rituximab Biosimilar
- URL: https://www.fdaweb.com/fda-panel-to-review-celltrion-rituximab-biosimilar/
- Published: 2018-09-12T12:00:00.000Z
- Updated: 2026-09-15T00:31:30.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5142334

*Federal Register* notice: FDA has announced a 10/10 Oncologic Drugs Advisory Committee meeting to review a Celltrion BLA for a proposed biosimilar to Genentech’s Rituxan (rituximab). The proposed indications are for the treatment of adult patients with (**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 CT–P10 in combination with chemotherapy, as single-agent maintenance therapy; and (**3**) non-progressing (including stable disease), low-grade, CD20-positive, B-cell NHL as a single agent after first-line cyclophosphamide, vincristine, and prednisone. To view the notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2018-09-12/pdf/2018-19741.pdf?ref=fdaweb.com).