3:09 PM
Oct 10, 2018
 |  BC Extra  |  Company News

FDA panel votes in favor of Celltrion's rituximab biosimilar

FDA's Oncologic Drugs Advisory Committee voted 16-0 Wednesday 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.

Celltrion received a complete response letter for CT-P10 in April. At the time the company said the CRL was related to a January warning letter from FDA citing GMP violations observed at Celltrion's manufacturing facility during production of Inflectra biosimilar infliximab-dyyb (CT-P13) (see "FDA Warns Celltrion of GMP Violations at Inflectra Facility").

In September, Celltrion said FDA completed a re-inspection of the facility.

In briefing documents released Oct. 5 ahead of the ODAC meeting, FDA reviewers said the CRL had also raised concerns regarding numerical differences in serious adverse events between CT-P10 and Rituxan in the supporting clinical study. The resubmitted BLA included data from a second study, which showed no differences in SAEs, according to the briefing documents.

Teva Pharmaceutical Industries Ltd. (NYSE:TEVA; Tel Aviv:TEVA) has exclusive rights to commercialize CT-P10 in the U.S. and Canada.

The biosimilar is approved in Europe as Truxima.

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