FDA panel votes in favor of Celltrion's rituximab biosimilar

FDA's Oncologic Drugs Advisory Committee voted 16-0 on Oct. 10 that a resubmitted BLA from Celltrion Inc. (KRX:068270) supports approval of CT-P10, its biosimilar of Rituxan/MabThera rituximab.

The panel backed the biosimilar's approval as a monotherapy to treat adults with relapsed or refractory, low-grade or follicular CD20-positive, B-cell non-Hodgkin lymphoma (NHL); as maintenance therapy for non-progressing NHL after chemotherapy; and in combination with first-line chemotherapy for previously untreated NHL...