FDA Approves First Rituximab Biosimilar

On Wednesday, the FDA approved the first biosimilar to Genentech’s RITUXAN®. The FDA’s press release noted that Teva and Celltrion’s biosimilar TRUXIMA® (rituximab-abbs) is the first biosimilar to be approved in the U.S. for the treatment of non-Hodgkin’s lymphoma. TRUXIMA® is indicated for treatment of adult patients for:

  • Relapsed or refractory, low grade or follicular, CD20-positive B-cell NHL as a single agent;
  • Previously untreated follicular, CD20-positive, B-cell NHL in combination with first line chemotherapy and, in patients achieving a complete or partial response to a rituximab product in combination with chemotherapy, as single-agent maintenance therapy; and
  • Non-progressing (including stable disease), low-grade, CD20¬ positive, B-cell NHL as a single agent after first-line cyclophosphamide, vincristine and prednisone (CVP) chemotherapy.

Genentech settled its litigation with Teva and Celltrion regarding this biosimilar earlier this month. Teva’s press release states that the terms and conditions of the settlement agreement, which includes entry terms, are confidential at this time.

This marks the sixth biosimilar the FDA has approved in 2018.

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