The approval of the Amgen product marks the third biosimilar approval in the United States since the beginning of 2020.
The FDA has approved Amgen's rituximab biosimilar Riabni, which references Rituxan and is indicated for the treatment of adult patients with non-Hodgkin lymphoma (NHL), chronic lymphocytic leukemia, granulomatosis with polyangiitis, and microscopic polyangiitis. Amgen said the product would be commercialized in the United States starting in January 2021.
The approval milestone follows recent US biosimilar launches for Amgen including a trastuzumab (Kanjinti, 2019) and bevacizumab (Mvasi, 2019). The company has 10 biosimilars in total, 5 approved in the United States and 3 available in the European Union.
Riabni is a CD20-directed cytolytic antibody that has demonstrated biosimilarity to the reference product via comparative analytical, nonclinical, and clinical data. The totality of evidence included a pharmacokinetic similarity study and comparative clinical study, Amgen said.
Efficacy, pharmacokinetics (PK), pharmacodynamics (PD), safety, tolerability and immunogenicity were evaluated in patients with grade 1, 2, or 3a follicular B-cell NHL and low tumor burden. Investigators enrolled 256 patients and randomized them 1:1 to receive 375 mg/m2 intravenously of either the biosimilar or reference product, once weekly for 4 weeks, followed by dosing at weeks 12 and 20.
Amgen said the primary end point was overall response rate by week 28, which was within the prespecified margin for equivalence to Rituxan. PK, PD, safety, and immunogenicity also were equivalent, and no meaningful differences in safety or effectiveness were detected.
The pharmaceutical company said Riabni will be marketed at a discount to the reference product of 23.7% below wholesale acquisition cost (WAC), or a WAC of $716.80 per 100 mg and $3584 per 500 mg single-dose vial. These costs are 15.2% less than the WAC for the biosimilar rituximab Truxima, Amgen said.
The company added that Riabni's average sales price will be 16.7% below the current average for Rituxan.
Eye on Pharma: Sandoz Files Antitrust Suit; Yuflyma Interchangeability; Costco’s Ustekinumab Pick
April 22nd 2025Sandoz's antitrust suit against Amgen, the FDA’s interchangeability designation for Celltrion’s adalimumab biosimilar, and the inclusion of an ustekinumab biosimilar in Costco’s prescription program highlight growing momentum to expand biosimilar access and affordability for patients with chronic inflammatory diseases.
How AI Can Help Address Cost-Related Nonadherence to Biologic, Biosimilar Treatment
March 9th 2025Despite saving billions, biosimilars still account for only a small share of the biologics market—what's standing in the way of broader adoption and how can artificial intelligence (AI) help change that?
Will the FTC Be More PBM-Friendly Under a Second Trump Administration?
February 23rd 2025On this episode of Not So Different, we explore the Federal Trade Commission’s (FTC) second interim report on pharmacy benefit managers (PBMs) with Joe Wisniewski from Turquoise Health, discussing key issues like preferential reimbursement, drug pricing transparency, biosimilars, shifting regulations, and how a second Trump administration could reshape PBM practices.
How State Substitution Laws Shape Insulin Biosimilar Adoption
April 15th 2025States with fewer restrictions on biosimilar substitution tend to see higher uptake of interchangeable insulin glargine, showing how even small policy details can significantly influence biosimilar adoption and expand access to more affordable insulin.
Latest Biosimilar Deals Signal Growth Across Immunology, Oncology Markets
April 14th 2025During Q1 2025, pharmaceutical companies accelerated biosimilar expansion through strategic acquisitions and partnerships in hopes of boosting patient access to lower-cost treatments in immunology and oncology.