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FDA advisory committee votes unanimously to approve Celltrion's Truxima

All Headlines 10:56 October 11, 2018

SEOUL, Oct. 11 (Yonhap) -- South Korean biopharmaceutical firm Celltrion Inc. said Thursday that an advisory committee for the U.S. Food and Drug Administration (FDA) recommended the approval of its biosimilar to treat certain kinds of cancer.

The Oncologic Drugs Advisory Committee (ODAC) held a meeting on Wednesday (local time) and voted 16-0 for Truxima to be approved for use in the United States. The drug is based on Rituxan, originally developed by Swiss pharmaceutical giant Roche Holding Ltd.

The FDA will take the committee's recommendation into consideration before giving the final greenlight, with the decision likely to be made by the end of the year, Celltrion said.

"We welcome the ODAC's recommendation. If taken up by the FDA, Truxima will be the first Rituxan biosimilar to be approved in the United States for the proposed uses," the company's CEO Kee Woo-sung said in a press release. "The development of biosimilars is of great importance in the field of oncology, and has the potential to increase accessibility to treatments for the patients."

The FDA holds such public advisory committee meetings before it makes decisions. The ODAC reviews and evaluates the safety and effectiveness of investigational human drug products for use in the treatment of cancer.

Truxima has been under FDA review since June following the resubmission of its application for marketing approval in May, when its first attempt failed due to production facility and manufacturing process issues.

The antibody biosimilar is used in the treatment of a number of diseases, including rheumatoid arthritis and non-Hodgkin's lymphoma, a type of leukemia.

FDA advisory committee votes unanimously to approve Celltrion's Truxima - 1


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