Biosimilar to Rituxan expected to hit market in January

December 22, 2020
Christine Blank

The biosimilar to Rituxan is expected to erode market share of the mainstay cancer drug for Roche.

FDA has cleared a new biosimilar to Rituxan rituximab (Rituxan), which when it gets on the market may further erode sales of Roche's blockbuster treatment for non-Hodgkin's lymphoma (NHL) and other cancers.

Amgen recently achieved FDA approval for rituximab-arrx (Riabni) to treat non-Hodgkin's lymphoma (NHL), chronic lymphocytic leukemia (CLL), granulomatosis with polyangiitis (GPA) (Wegener's Granulomatosis), and microscopic polyangiitis (MPA).

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The biosimilar is expected to be available in January. Sales of Roche's Rituxan reached $6.54 billion in 2019, so any competitor to Rituxan has much to gain.

Riabni’s wholesale acquisition cost (WAC) in the U.S. is nearly 24% lower than Rituxan at $716.80 per 100 mg and $3,584.00 per 500 mg single-dose vial, according to an Amgen press release.

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The FDA approved Celltrion's rituximab-abbs (Truxima), the first biosimilar to Rituxan, in 2018. The agency approved Pfizer's Ruxience (rituximab-pvvr) a year later.

Riabni, a CD20-directed cytolytic antibody, was proven to be highly similar to Rituxan based on a totality of evidence, which included comparative analytical, nonclinical and clinical data, with no clinically meaningful differences in safety or effectiveness, Amgen said.

Read more: FDA grants full approval for combination leukemia treatment

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