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Oncologic Drugs Advisory Committee

On Wednesday, October 10, 2018, from 8 am to 11:30 am US EST, the Oncologic Drugs Advisory Committee (ODAC) discussed the resubmission of a biologics license application (BLA) for CT-P10, a proposed biosimilar of Rituxan (rituximab) by Celltrion, Inc. (Celltrion). Pending licensure, Teva Pharmaceutical Industries, Ltd is responsible for all commercial activities of CT-P10 in the US.

The committee voted unanimously (16 of 16 member) that the totality of the evidence support the licensure of CT-P10 as a biosimilar product of Rituxan for the following 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; and

·      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.