Expert Committee Supports Celltrion’s Proposed Rituxan Biosimilar

An FDA advisory committee voted in favor of licensing Celltrion’s drug candidate as a biosimilar for Roche’s blockbuster cancer-fighting Rituxan (rituximab).

The Oncologic Drugs Advisory Committee voted 16-0 that the totality of evidence supported Truxima’s similarity to Rituxan for treatment of three forms of non-Hodgkin’s lymphoma in adult patients.

Committee chairperson Brian Rini, a professor of medicine at the Lerner College of Medicine in Cleveland, said the clinical data supported efficacy in terms of response rate, and that any discrepancies in the safety data were likely simply “what you get when you have a lower number of patients treated in this type of development program.”