![From QSR to QMSR: Meeting FDA’s New Requirements From QSR to QMSR: Meeting FDA’s New Requirements](https://www.fdanews.com/ext/resources/Book-Covers-NEW/From-QSR-to-QMSR-500.png?height=200&t=1714569011&width=200)
Home » Pfizer’s MabThera Biosimilar Nabs European Approval
Pfizer’s MabThera Biosimilar Nabs European Approval
April 3, 2020
The European Commission has approved Pfizer’s Ruxience (rituximab) for treatment of non-Hodgkin’s lymphoma, chronic lymphocytic leukemia, rheumatoid arthritis, granulomatosis with polyangiitis and microscopic polyangiitis, and pemphigus vulgaris.
The approval was based on the results of a clinical trial that found no clinically meaningful differences in the drug’s safety or efficacy compared to Roche’s MabThera in patients with CD20-positive, low-tumor-burden follicular lymphoma.
Ruxience was recently made available to adult patients in the U.S. for several of the same indications and launched in Japan in January.
Upcoming Events
-
21Oct