Sword refers to Roche Merro! Amgen Lytoxi monobial-like drug Riamni is approved by the FDA!

December 18, 2020 // -- Amgen recently announced that the U.S. Food and Drug Administration (FDA) has approved Ribni (rituximab-arrx, rituximab-rituximab), a Roche ace biologic agent Rituxan (Chinese Product Name: Meroma, generic name: rituximab, rituximab, rituximab biosynthetic drug for the treatment of non-Hodgkin's lymphoma (NHL), chronic lymphocytic leukemia (CLL), granuloma with polyvascularitis (GPA), microscopic multi-hemanitis (MPA) adult patients.
is expected to go public in the U.S. in January 2021.
Rituxan is a therapeutic monoclonal antibody targeting CD20 that has been approved in several countries around the world for treatment of: (1) a variety of oncology adaptations, including NHL, CLL;
currently, there are 10 biosypolytes in the pipeline, five of which have been approved in the United States and three in the European Union.
According to the FDA Biosynthics Database, the FDA has so far approved 29 biosynthic drugs, 10 of which are for Roche's three ace biologics: Avastin (Avastin, Bevastatin, 2), Herceptin, Qutoju monomatin, 5), Rituxan, Rituxian monoantigen, and 3.
three of the Rituxan biosynthic drugs are Riabni, Ruxience (Pfizer), truxima (Teva/Celltrion).
, Riabni's wholesale purchase costs (WAC) in the U.S. will be 23.7 percent lower than rituxan, the reference drug.
100mg WACA was $716.80 and the 500mg single-dose vial was $3584.00, 23.7 per cent lower than Ritham's WACA, 15.2 per cent lower than Truxima's WACA and in line with Ruxience's WACA.
will be 16.7 per cent lower than the current average selling price (ASP) for Riuxan when it companies go public.
Riabni is available from wholesalers and professional distributors.
Gordon, Executive Vice President of Global Business Operations at Amni, said, "Riabni's approval represents an important milestone in the field of biosynamics and oncology.
Following the success of Kanjinti (trastuzumab-anns, trastuzumab-anns) and Mvasi (bevacizumab-awwwb) in the U.S. market, Riabni reaffirmed Amgen's long-standing commitment to providing high-quality biosimons that provide more affordable and effective treatment options for cancer and other serious diseases that will contribute to the sustainability of the healthcare system.
"Riabni's active pharmaceutical ingredient is a CD20-oriented soluble cellular monoclonal antibody with the same amino acid sequence as Rithuxan.
based on comparative analysis, non-clinical, and clinical data, Riabni has been shown to be highly similar to Rituxan, with no clinically significant differences in safety and ability.
Riabni's packet includes results from a pharmacodynamics (PK) similarity study and a comparative clinical study.
This randomized, double-blind, comparative clinical study evaluated the efficacy, pharmacogenetics (PK), pharmacodynamics (PD), safety, tolerability, and immunogenicity of Riabni and Rithuxan in patients with level 1, 2 or 3a fistertic B cell NHL and low tumor load.
study included 256 subjects who were randomly (1:1) assigned to Riabni or Rithuxan intravenous infusion therapy at doses of 375 mg/m2, once a week for four weeks, and then administered again at weeks 12 and 20, respectively.
end point is the assessment of the Total Mitigation Rate (ORR) at week 28.
data show that differences in ORR between Riabni and Rithuxan show clinical ethonthority within pre-defined limits.
KR, PD, security and immunogenicity of Riamni are similar to Rituxan.
() original source: Amgen's RIABNI wins FDA approval for multiple disorders