Celltrion

December 4, 2018

Truxima Becomes First Biosimilar to Rituxan Approved in US for Non-Hodgkin’s Lymphoma

News

The U.S. Food and Drug Administration has approved Truxima (rituximab-abbs), a biosimilar to Rituxan (rituximab), for three CD20-positive non-Hodgkin’s lymphoma indications, Celltrion and Teva announced. The decision comes less than two months after the FDA’s Oncologic Drugs ... Read more

October 15, 2018

FDA Committee Recommends Truxima’s Approval for 3 Non-Hodgkin’s Lymphoma Indications

News

Truxima (CT-P10) a biosimilar to Rituxan (rituximab), has been unanimously recommended for approval by the U.S. Food and Drug Administration’s Oncologic Drugs Advisory Committee for the treatment of three non-Hodgkin’s lymphoma (NHL) indications, ... Read more

July 11, 2017

FDA Will Review Application Seeking Approval of Truxima for Same Indications as Rituxan

News

The U.S. Food and Drug Administration has accepted for review the biologics license application (BLA) requesting the approval of Truxima (CT-P10), a biosimilar to Rituxan (rituximab), for the treatment of ... Read more