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Celltrion’s Rituxan biosimilar gets unanimous backing from FDA committee

15 oktober 2018
InPharm.com

FDA approval looks to be in reach for Celltrion, as an advisory committee for the US regulator voted unanimously to recommend Truxima, its biosimilar version of Roche’s Rituxan (rituximab), in the treatment of cancer. All 16 members of the Oncologic Drugs Advisory Committee (ODAC) backed the decision, and while the FDA is not beholden to the recommendation, it is thought that it could greatly influence its final verdict, which is expected by the end of this year.

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