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Oct 12, 2018
 |  BC Week In Review  |  Clinical News  |  Regulatory

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...

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