Europe’s CHMP recommends Pfizer’s biosimilar of Roche’s MabThera
The EMA’s Committee for Medicinal Products for Human Use (CHMP) has revealed that it has awarded a positive opinion for Pfizer’s Ruxience, a biosimilar version of Roche’s MabThera (rituximab).
Upon review of submitted data, the CHMP found no clinically meaningful differences between the two products, confirming Ruxience’s biosimilarity to MabThera.
CHMP recommendation is not binding, but the EMA regularly follows them with its final appraisals. If the therapy goes on to secure approval off the back of the CHMP recommendation, it would become a treatment option for the same conditions as its reference product, including for the treatment of non-Hodgkin’s lymphoma, chronic lymphocytic leukaemia, rheumatoid arthritis, granulomatosis with polyangiitis and microscopic polyangiitis, and pemphigus vulgaris.
“Biosimilars like Ruxience can play an important role in cancer care, helping to expand patient access to potentially life-changing therapies,” said Dr Chris Boshoff, Chief Development Officer, Oncology, at Pfizer Global Product Development. “We are committed to bringing biosimilars like Ruxience to the market as a treatment option with similar safety and efficacy to the originator product at a potentially lower cost. If approved, Ruxience would become Pfizer’s fifth oncology biosimilar to receive regulatory approval in Europe.”
A final decision is expected this year.
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