Truxima (rituximab) gains FDA approval as the first biosimilar for Non-Hodgkin's Lymphoma
Truxima (rituximab) is the first biosimilar of the medicine Rituxan (rituximab) to be approved by the US Food and Drug Administration (FDA). A biosimilar is a biologic medicine that is an almost identical version of the original medicine.
Having most indications in common with Rituxan (rituximab), Truxima (rituximab) is used to treat patients with follicular lymphoma and diffuse large B-cell non-Hodgkin’s lymphoma, chronic lymphocytic leukaemia, severe active rheumatoid arthritis, granulomatosis with polyangiitis, and microscopic polyangiitis.
Data on the new medicine's structural and functional characterisation, and clinical study results, formed the basis for the FDA's approval decision. Two randomised, double-blinded trials showed no clinically meaningful differences between Truxima (rituximab) and reference medicine. Compared to the control, patients in each of the two trials had high overall response rates (ORRs) for both Truxima (rituximab) and the reference medicine, Rituxan (rituximab). In the first trial, the ORRs were 95.7% and 90.0% respectively, while the ORRs of the second trial were 83.1% and 81.3% respectively.
Truxima (rituximab) marks the third biosimilar to be approved by the FDA in November. In a press release, FDA Commissioner Scott Gottlieb, MD, said, "As part of the FDA's Biosimilars Action Plan, we’re advancing new policies to make the development of biosimilars more efficient and to enable more opportunities for biosimilar manufacturers to make these products commercially successful and competitive. Our goal is to promote competition that can expand patient access to important medicines".
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