Riabni is a cytolytic antibody that works similar to Rituxan, with no clinically meaningful differences in safety or effectiveness
Amgen headquarters in Thousand Oaks, California. (Credit: Coolcaesar/Wikipedia.)
Amgen has received the US Food and Drug Administration (FDA) approval for Riabni (rituximab-arrx), its biosimilar to Roche’s Rituxan (rituximab), to treat certain cancers types.
The FDA approval indicated Riabni for the treatment of Non-Hodgkin’s Lymphoma (NHL), Chronic Lymphocytic Leukemia (CLL), Granulomatosis with Polyangiitis (GPA) (Wegener’s Granulomatosis), and Microscopic Polyangiitis (MPA).
The US-based biopharmaceutical firm is planning to commercialise its biosimilar cancer treatment Riabni in the US, in January 2021.
Roche’s subsidiary Genentech has secured the US FDA approval for Rituxan to treat GPA and MPA in paediatric patients aged two years and above.
Amgen global commercial operations executive vice president Murdo Gordon said: “The approval of RIABNI represents an important milestone across our biosimilar and oncology portfolios.
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.”
Riabni is a cytolytic antibody similar to Rituxan, based on comparative analytical, nonclinical and clinical data, with no clinically meaningful differences in safety or effectiveness.
The active ingredient of Riabni features the same amino acid sequence, along with similar strength, dosage form and route of administration as Rituxan IV formulation.
A randomised, double-blind, comparative clinical study evaluated the efficacy, pharmacokinetics (PK), pharmacodynamics (PD), safety, tolerability and immunogenicity of Riabni compared to Rituxan.
In the study, 256 patients were enrolled and randomised in a 1:1 ratio to receive 375mg/m2 intravenous infusion dose of either Riabni or Rituxan, once weekly for 4 weeks followed by dosing at weeks 12 and 20.
The assessment of overall response rate (ORR) for treatment using Riabni was within the prespecified margin by week 28, which is the primary endpoint, compared to Rituxan, showing clinical equivalence.
Also, the treatment using Riabni demonstrated a similar PK, PD, safety and immunogenicity to that of Rituxan.
Amgen’s portfolio comprises a total of 10 biosimilars, of which five have been approved in the US, and three approved in the European Union (EU).