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New Drugs Approved In December

Riabni
Riabni

The FDA approved Riabni developed by Amgen Inc. (AMGN) on December 17, 2020.

Riabni (rituximab-arrx), a biosimilar to Roche's Rituxan is indicated for the treatment of adult patients with Non-Hodgkin's Lymphoma (NHL), Chronic Lymphocytic Leukemia (CLL), Granulomatosis with Polyangiitis (GPA) (Wegener's Granulomatosis), and Microscopic Polyangiitis (MPA).

The Wholesale Acquisition Cost for Riabni is $716.80 per 100 mg and $3,584.00 per 500 mg single-dose vial, 23.7% lower than the reference product, Rituxan

According to analysts at GlobalData, Riabni could rake in sales of about $4 billion by 2025.

Teva/Celltrion’s Truxima and Pfizer's Ruxience are other bilosimialars to Rituxan, approved by the FDA.