On December 17th, the US Food and Drug Administration (FDA) approved Rianbi (rituximab-arrx). Rianbi (rituximab-arrx) is manufactured by Amgen and the third FDA-approved biosimilar to Genentech’s Rituxan (rituximab). It is the third biosimilar FDA has approved in 2020 and the 29th approved in the past 5 years.
Read more about the successes FDA’s of the biosimilar program here.
Rianbi (rituximab-arrx) is indicated to treat adult patients with non-Hogkin’s lymphoma, chronic lymphocytic leukemia, granulomatosis with polyangiitis and microscopic polyangiitis.
Rianbi (rituximab-arrx) will launch in January 2021. According to the manufacturer, its wholesale acquisition cost (WAC) will be 23.7% lower than the originator, 15.2% lower than Truximab (rituximab-abbs) and comparable to that of Ruxience (rituximab-pvvr). At launch its average sale price (ASP) will be 16.7% lower than the originator.
Learn more about the approval here.
Read the label/packaging insert for Rianbi (rituximab-arrx) here.