FDA Approves Rituxan Biosimilar, Riabni, For Patients with Non-Hodgkin Lymphoma, Chronic Lymphocytic Leukemia, and Two Blood Vessel Disorders

The Food and Drug Administration (FDA) on Thursday approved the biosimilar Riabni (rituximab-arrx) for the treatment of adult patients with non-Hodgkin lymphoma (NHL), chronic lymphocytic leukemia (CLL), granulomatosis with polyangiitis (GPA; Wegener's Granulomatosis) and microscopic polyangiitis (MPA), according to the biosimilar’s manufacturer, Amgen.

Riabni is a CD20-directed cytolytic antibody that was found to be highly similar to the antibody therapy Rituxan (rituximab) based on the evidence of a randomized, double-blind, comparative clinical study that evaluated the efficacy, pharmacokinetics (PK), pharmacodynamics (PD), safety, tolerability and immunogenicity of Riabni compared to Rituxan in patients with grade 1, 2 or 3a follicular B-cell NHL and low tumor burden. Among 256 patients, Riabni had a similar clinical equivalence to Rituxan by week 28 when assessing for overall response to therapy.

"The approval of Riabni represents an important milestone across our biosimilar and oncology portfolios," said Murdo Gordon, executive vice president of Global Commercial Operations at Amgen in a company-issued press release. "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 health care systems."

Biosimilars are drugs that are highly similar to original biomedical products and are approved along the same standards by the FDA as the original drug. Biosimilars allow for wider access to therapies and also lower the costs of treatment with a drug available that functions similar to the original drug without as much production burden or exclusivity. In the case of Riabni according to Amgen, the list price in the U.S. will be 23.7% lower than Rituxan. Riabni will cost $716.80 per 100 mg and $3,584.00 per 500 mg single-dose vial at list price and is identical to the intravenous doses of Rituxan, according to Amgen.

The boxed warning for side effects on Riabni is similar to Rituxan including reactions to infusions that can be severe or prove fatal in some cases, severe skin and mucous membrane reactions, hepatitis B virus reactivation in patients who had hepatitis B previously and the rare infection of the brain caused by John Cunningham virus progressive multifocal leukoencephalopathy.

Riabni is expected to be available to wholesalers and specialty distributors in the U.S. by January 2021.

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