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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).
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.
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.