FILE PHOTO: The logo of Celltrion is seen at company’s headquarters in Incheon, South Korea, October 28, 2016. REUTERS/Kim Hong-Ji
(Reuters) – The U.S. Food and Drug Administration on Wednesday approved Celltrion Inc’s Truxima, making it the first biosimilar to Roche Holding AG’s Rituxan available in the United States to treat non-Hodgkin’s lymphoma.
The approval was largely expected as the drug won unanimous backing from an FDA advisory panel in October, which deemed it highly similar to Rituxan.
The FDA had in February declined to approve the copycat drug, citing issues related to a certain manufacturing process at Celltrion’s facility.
Like Rituxan, Truxima’s label contains a boxed warning – the agency’s harshest – which highlights several health risks including a rare, serious brain infection and liver damage.
Roche’s drug, approved in 1997, is marketed as Rituxan in the United States, Japan and Canada and as MabThera elsewhere.
In October, Roche said it expected biosimilar competition in the United States in the first half of 2019.
Earlier this month, Novartis International AG said it would no longer pursue U.S. regulatory approval for its biosimilar of Rituxan after the FDA sought additional information to support the company’s application for the drug.
Celltrion entered into a partnership with Teva Pharmaceutical Industries in 2016 to commercialize Truxima in United States and Canada.
Reporting by Manas Mishra and Tamara Mathias in Bengaluru; Editing by Shailesh Kuber
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