
Pfizer scores EU approval for MabThera biosimilar Ruxience
pharmafile | April 6, 2020 | News story | Sales and Marketing | MabThera, Pfizer, Ruxience, biosimilar
The European Commission has moved to authorise Ruxience, Pfizer’s biosimilar version of MabThera (rituximab). The decision marks the seventh biosimilar approval for Pfizer in Europe.
The approval authorises the drug for the same indications as its reference product, including the treatment of non-Hodgkin’s lymphoma, chronic lymphocytic leukaemia, rheumatoid arthritis, granulomatosis with polyangiitis and microscopic polyangiitis, and pemphigus vulgaris.
“Biosimilars like Ruxience exhibit a similar safety and efficacy profile to the originator product and have the potential to improve treatment access while reducing healthcare costs,” explained Masum Hossain, Regional President, Oncology International Developed Markets at Pfizer. “Building on our ongoing commitment to bring biosimilars to market, we look forward to making Ruxience available to patients in the EU in the coming months.”
The decision was motivated by data supporting the biosimilarity of Ruxience to MabThera, finding no clinically meaningful difference between the two in terms of efficacy, safety, immunogenicity or pharmacodynamics, including in patients with CD20-positive, low tumour burden follicular lymphoma.
It follows a recommendation awarded to the drug in this indication back in January by the EC’S Committee for Medicinal Products for Human Use.
Matt Fellows
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