Amgen (AMGN) Confirms FDA Approves its RIABNI, A Biosimilar To Rituxan (rituximab)
- S&P 500 closes at record high as Apple, healthcare stocks help shrug off Delta worries
- Tencent (TCEHY) Falls Sharply as State Media Describes Online Games as ‘Spiritual Opium’, Company Vows to Improve
- Oil settles lower in volatile trade on worries about Delta variant
- Clorox (CLX) Falls Sharply as COVID-19 Demand Wanes
- Dollar steadies as markets weigh economic risks, central bank moves
Get instant alerts when news breaks on your stocks. Claim your 1-week free trial to StreetInsider Premium here.
Amgen (NASDAQ: AMGN) today announced that the U.S. Food and Drug Administration (FDA) has approved RIABNI™ (rituximab-arrx), a biosimilar to Rituxan® (rituximab), for the treatment of adult patients with Non-Hodgkin's Lymphoma (NHL), Chronic Lymphocytic Leukemia (CLL), Granulomatosis with Polyangiitis (GPA) (Wegener's Granulomatosis), and Microscopic Polyangiitis (MPA). RIABNI will be made available in the U.S. in January 2021.
"The approval of RIABNI represents an important milestone across our biosimilar and oncology portfolios," said Murdo Gordon, executive vice president of Global Commercial Operations at Amgen. "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, a CD20-directed cytolytic antibody, was proven to be highly similar to Rituxan based on a totality of evidence, which included comparative analytical, nonclinical and clinical data, with no clinically meaningful differences in safety or effectiveness. The data package was composed of, in part, results from a pharmacokinetic (PK) similarity study and a comparative clinical study.
The randomized, double-blind, comparative clinical study evaluated the efficacy, pharmacokinetics (PK), pharmacodynamics (PD), safety, tolerability and immunogenicity of RIABNI compared to Rituxan in subjects with grade 1, 2, or 3a follicular B-cell NHL and low tumor burden. There were 256 patients enrolled and randomized (1:1) to receive 375 mg/m2 intravenous infusion of either RIABNI or Rituxan, once weekly for 4 weeks followed by dosing at weeks 12 and 20. The primary endpoint, an assessment of overall response rate (ORR) by week 28, was within the prespecified margin for RIABNI compared to Rituxan, showing clinical equivalence. PK, PD, safety and immunogenicity of RIABNI were similar to Rituxan.
The Wholesale Acquisition Cost (WAC or "list price") of RIABNI in the U.S. will be 23.7% lower than the reference product, Rituxan. RIABNI is being made available at a WAC of $716.80 per 100 mg and $3,584.00 per 500 mg single-dose vial, 23.7% less than the WAC for Rituxan, 15.2% less than the WAC for Truxima® (biosimilar to Rituxan) and matching the WAC for Ruxience® (biosimilar to Rituxan). At launch, RIABNI will be priced 16.7% below the current Rituxan Average Selling Price (ASP). RIABNI will be available from both wholesalers and specialty distributors.
Amgen has a total of 10 biosimilars in its portfolio, five of which have been approved in the U.S., and three that are approved in the European Union (EU).
tional Important Safety Information.
Serious News for Serious Traders! Try StreetInsider.com Premium Free!
You May Also Be Interested In
- Amgen (AMGN) to Build Second New Manufacturing Facility in the U.S.
- Monopar Therapeutics (MNPR) Announces FDA Clearance to Proceed with Camsirubicin Clinical Trial Targeting Advanced Soft Tissue Sarcoma
- ErosSTX Global (ESGC) Files an Extension for its Fiscal 2021 Annual Report; Provides Debt Restructuring Update
Create E-mail Alert Related CategoriesCorporate News, FDA, Management Comments
Related EntitiesDavenport, Twitter, Dividend, Definitive Agreement, FDA
Sign up for StreetInsider Free!
Receive full access to all new and archived articles, unlimited portfolio tracking, e-mail alerts, custom newswires and RSS feeds - and more!