Amgen’s Riabni (biosimilar, rituximab) Receives the US FDA’s Approval for Multiple Diseases

December 18, 2020 Auto Bot Adult, Amgen, approval, Biosimilar, Biosimilars, patients, receives, Rituxan, Rituximab, Us FDA 0

Shots:

  • The approval is based on trial assessing Riabni (375 mg/m2, IV) vs Rituxan once weekly for 4wks. followed by dosing @12wks. & 20wks. in 256 patients in a ratio (1:1) with grade 1, 2, or 3a follicular B-cell NHL & low tumor burden
  • The WAC of Riabni will be 23.7% lower than the Rituxan in the US and will be available at a WAC of $716.80/ 100mg and $3,584.00/ 500mg single-dose vial
  • Riabni is a biosimilar to Rituxan, approved for the treatment of NHL, CLL, GPA, MPA and ill be made available in the US in Jan 2021

Click here ­to­ read full press release/ article | Ref: PRNewswire | Image: Adweek

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