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(LEAD) Celltrion wins FDA approval for Truxima

Industry 10:01 November 29, 2018

(ATTN: UPDATES with more info throughout)
By Kim Han-joo

SEOUL, Nov. 29 (Yonhap) -- South Korean biopharmaceutical firm Celltrion Inc. said Thursday that it has won sales approval from the U.S. Food and Drug Administration (FDA) for Truxima.

Truxima -- based on Rituxan, originally developed by Swiss pharmaceutical giant Roche Holding Ltd -- is Celltrion's second biosimilar to receive the green light from the FDA.

Truxima is used in the treatment of a number of diseases in adult patients, including rheumatoid arthritis and non-Hodgkin's lymphoma, a type of leukemia.

"The approval of Truxima is a significant milestone for Celltrion and, more notably, for the patients who need access to this important medication," CEO Kee Woo-sung said. "Truxima is the very first rituximab biosimilar to be approved in the United States for three non-Hodgkin's lymphoma indicators and may help provide greater accessibility for patients."

The FDA approval gives Celltrion a "first-mover" status in the U.S. rituximab industry that is estimated at around 5 trillion won (US$4.4 billion), accounting for 56 percent of the global sales.

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 approval of the drug comes after an unanimous recommendation of approval by the FDA's Oncologic Drug Advisory Committee last month.

Teva Pharmaceutical Industries Ltd. will market Truxima in the United States. The two companies entered into an exclusive partnership in October 2016 to commercialize the biosimilar in the U.S. and Canada.

"This is an exciting time to be involved in the biosimilars space, and we look forward to bringing the product to market," said Brendan O'Grady, executive vice president and head of North America Commercial at Teva, in a press release by Celltrion.

Truxima was also the first biosimilar cancer drug to hit the European market in 2017. The drug is sold in 28 European Union countries and is also planned to hit the Middle East.

(LEAD) Celltrion wins FDA approval for Truxima - 1


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