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Amgen wins FDA OK for biosimilar Rituxan


Adult patients with several types of cancer will soon have a new biosimilar medication to treat their disease.

The Food and Drug Administration has cleared Amgen’s Riabni (rituximab-arrx), a biosimilar of Genentech's Rituxan (rituximab). It is indicated to treat adult patients with non-Hodgkin's lymphoma, chronic lymphocytic leukemia, granulomatosis with polyangiitis and microscopic polyangiitis.

"The approval of Riabni represents an important milestone across our biosimilar and oncology portfolios," said Murdo Gordon, Amgen executive vice president of global commercial operations.

"Following the proven success of Kanjinti (trastuzumab-anns) and Mvasi (bevacizumab-awwb) in the U.S. marketplace, Riabni reaffirms Amgen's long-term commitment to providing high quality biosimilars that can potentially offer more affordable, effective treatment options for cancer and other serious diseases and that contribute to the sustainability of healthcare systems."

The wholesale acquisition cost, or WAC, of Riabni will be 23.7% lower than Rituxan, said Amgen, which is listing Riabni at a WAC of $716.80 per 100 mg and $3,584.00 per 500 mg single-dose vial. The price also is 15.2% less than the WAC for fellow biosimilar Truxima and matches the WAC for another biosmilar Rituxan, Ruxience. At launch, Riabni will be priced 16.7% below the current Rituxan average selling price. Riabni will be available from both wholesalers and specialty distributors.

The company expects that Riabni will be available in January 2021.

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