FDA Approves Celltrion's Truxima As Biosimilar to Genentech's Rituxan
November 28 2018 - 2:42PM
Dow Jones News
By Michael Dabaie
The U.S. Food and Drug Administration on Wednesday approved
Celltrion Inc.'s (068270.SE) Truxima as a biosimilar to Genentech's
Rituxan for the treatment of adult patients with CD20-positive,
B-cell non-Hodgkin's lymphoma to be used as a single agent or in
combination with chemotherapy.
Truxima is the first biosimilar to be approved in the U.S. for
the treatment of non-Hodgkin's lymphoma, the FDA said.
Genentech is part of Roche Holding AG (ROG.EB).
The FDA said its approval of Truxima is based on a review of
evidence that included extensive structural and functional
characterization, animal study data, human pharmacokinetic data,
clinical immunogenicity data, and other clinical data. Truxima has
been approved as a biosimilar, not as an interchangeable product,
the FDA said.
Write to Michael Dabaie at michael.dabaie@wsj.com
(END) Dow Jones Newswires
November 28, 2018 14:27 ET (19:27 GMT)
Copyright (c) 2018 Dow Jones & Company, Inc.
Roche (QX) (USOTC:RHHBY)
Historical Stock Chart
From Mar 2024 to Apr 2024
Roche (QX) (USOTC:RHHBY)
Historical Stock Chart
From Apr 2023 to Apr 2024
