Big Molecule Watch
July 30, 2019

FDA Approves RUXIENCE, Pfizer’s Rituximab Biosimilar Product

On July 23, 2019, the FDA approved Pfizer’s aBLA for RUXIENCE (rituximab-pvvr), a biosimilar of Genentech’s RITUXAN.  According to its approved package insert, RUXIENCE is indicated for the treatment of certain types of non-Hodgkin’s lymphoma, chronic lymphocytic leukemia, granulomatosis with polyangiitis (Wegener’s Granulomatosis), and microscopic polyangiitis.

RUXIENCE is the twenty-second biosimilar product overall to obtain FDA approval and the second rituximab biosimilar, following Celltrion’s TRUXIMA (rituximab-abbs) in November 2018.

As noted in Pfizer’s press release, RUXIENCE is Pfizer’s third oncology biosimilar product to be approved by FDA this year.

We are not aware of any pending BPCIA litigation concerning RUXIENCE, but Pfizer and Biogen previously settled IPRs on patents related to rituximab.

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