Pfizer garners EU approval for MabThera biosimilar Ruxience

Pfizer announced Thursday that the European Commission has approved Ruxience (rituximab), a biosimilar referencing Roche's MabThera (rituximab) for the treatment of non-Hodgkin's lymphoma (NHL), chronic lymphocytic leukaemia (CLL), rheumatoid arthritis (RA), granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA), as well as pemphigus vulgaris. Masum Hossain, regional president for oncology international developed markets at Pfizer, said "we look forward to making Ruxience available to patients in the EU in the coming months."

The approval comes after a positive opinion was issued by the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) in January. Pfizer said the filing was based on a comprehensive data package that included results from the Phase III REFLECTIONS B3281006 trial, which found "no clinically meaningful differences" in safety or efficacy between Ruxience and MabThera in patients with CD20-positive, low-tumour-burden follicular lymphoma.

According to Pfizer, Ruxience was recently made available to adult patients in the US where it was approved last July for the treatment of NHL, CLL, GPA and MPA. The biosimilar, formerly known as PF-05280586, was also launched in Japan this past January.

In 2017, EU regulators approved Celltrion and Teva's MabThera biosimilar Truxima (rituximab-abbs) to treat patients with NHL, CLL, RA, GPA and MPA. Truxima was also cleared in the US the following year.

Roche recently reported that MabThera, which is marketed as Rituxan in the US and some other markets, generated sales of CHF 1.5 billion ($1.5 billion) in last year's fourth quarter, down 6% from the prior-year period, hit by biosimilar competition in Europe and Japan.

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