Amiri's biosynthic drug RIABNI has been approved for listing by the FDA

On December 17th, Amgen announced that the U.S. Food and Drug Administration® (FDA) had approved the bio-similar drug RIABNI™ (Rituxan ®, Rituximab, Rituximab) Ritrituximab-arrx is listed in the United States for the treatment of adult non-Hodgkin's lymphoma (NHL), chronic lymphocytic leukemia (CLL), granuloma polymangiotisitis (GPA) (Wagner's granuloma) and microscopic multivascularitis (MPA).
RIABNI will go on sale in January 2021.
RIABNI is a CD20-oriented soluble cellular antibody with the same amino acid sequence as Merohua.
based on comparative analysis, pharmacodynamics (PK) similarity studies, non-clinical and clinical data confirm that there is no clinical difference in safety and ability between RIABNI and Melohua.
In a randomized, double-blind, clinically comparative study, 256 patients with grade 1, grade 2 or 3a filatic B-cell lymphoma and patients with low tumor mutation load (TMB-L) were randomly grouped at 1:1 to receive 375 mg/m2 RIABNI or Merobhua infusions, one week for four weeks, followed by 12th and 20th weeks.
The main clinical endpoints are the assessment of the overall response rate (ORR) in week 28, whether RIABNI and Melohua exhibit clinical ethonism within a preset range, pharmacogenesis (PK), pharmacoetics (PD), safety, tolerance and immunogenicity differences, etc.
approval of the listing, RIABNI's wholesale purchase price (WAC or list price) in the United States will be 23.7% lower than that of similar Merohua and the average selling price (ASP) will be 16.7% lower than melohua's 7%, 15.2% cheaper than the Truxima ®, developed by Teva and partner Korean biopharmaceutical company Celltrion, and similar to Pfizer's Merova biosimilar Ruxience ® price.
RIABNI is listed at $716.8/100 mg and $3,584/500 mg in single-dose bottles, respectively.
10 biosypolybic drugs in amsin's portfolio, five of which have been approved by the FDA in the United States and three in the European Union.
in the United States, RIABNI approved adaptations include: non-Hodgkin's lymphoma (NHL), including: relapse or refragsive, low grade or folytic, CD20 positive, single drug treatment for B-cell lymphoma.
previously untreated filtration, CD20-positive, B-cell lymphoma combined with first-line chemotherapy, and patients who achieved a full or partial response to lysoxi monoantigen combination chemotherapy were treated as single-drug maintenance.
after first-line chemotherapy of cyclophosphamide, chrysoxine and strong pine (CVP), there was no progression (including stable condition), low level, CD20 positive, single-drug treatment of B-cell lymphoma.
Previously untreated diffuse large B cells, CD20-positive lymphoma combined with cyclophosphamide, amycin, chrysanthong, strong pine (CHOP) or other chemotherapy programs based on cyclocycline.
chronic lymphocytic leukemia (CLL) RIABNI combined with fluorodalabin and cyclophosphamide (FC), which can be used to treat adult patients with CD20-positive CLL that has not been treated or treated in the past.
the treatment of granuloma multi-angiolysis (GPA) (Wagner's granuloma) and microscope polyvascularitis (MPA) RIABNI combined with glucosticoids, suitable for the treatment of adult granuloma multi-angiotisitis (GPA) (Wagner's granuloma) and microscope polyvascularitis (MPA).
source: FDA Approves Amgen's RIABNI™ (rituximab-arrx), A Biosimilar To Rituxan ® (rituximab)