Pfizer obtains European approval for biosimilar to Mabthera

April 2020 Pharma News Willem van Altena
Abstract European Union flag

Pfizer has received EMA approval for Ruxience (rituximab-pvvr), a monoclonal antibody (mAb) and biosimilar to MabThera (rituximab). The approval allows for the drug’s use to treat non-Hodgkin’s lymphoma (NHL), chronic lymphocytic leukaemia (CLL), rheumatoid arthritis (RA), granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA) and pemphigus vulgaris (PV).

Approval was granted based on data showing the drug’s biosimilarity to MabThera, including results from the REFLECTIONS B3281006 clinical comparative study, which assessed the efficacy, safety and immunogenicity, pharmacokinetics and pharmacodynamics of Ruxience.

Biosimilars such as Ruxience show a similar treatment profile and similar side effects as the original product. Other biosimilars, that have received EMA clearance this year for the same indications are Rixathon and Truxima. Approval of these biosimilars offers extra treatment options to specialists, at a lower cost. Biosimilars have the potential to improve access to certain treatments, and remain cost-efficient at the same time


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