Teva and Celltrion Launch Rituximab Biosimilar in US

On November 7, Teva Pharmaceuticals USA, Inc., and Celltrion, Inc., announced that TRUXIMA® (rituximab-abbs) will be available in the United States beginning November 11. As we previously reported, TRUXIMA® is the first biosimilar to Genentech’s RITUXAN® (rituximab) to gain FDA approval and is currently approved for the treatment of adult patients with the following indications:

  • Non-Hodgkin’s Lymphoma (NHL)
    • 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
    • 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
    • Previously untreated diffuse large B-cell, CD20-positive NHL in combination with (cyclophosphamide, doxorubicin, vincristine, and prednisone) (CHOP) or other anthracycline-based chemotherapy regimens
  • Chronic Lymphocytic Leukemia (CLL)
    • In combination with fludarabine and cyclophosphamide (FC), for the treatment of adult patients with previously untreated and previously treated CD20-positive CLL

According to Teva’s press release, “[i]n light of a patent settlement with Genentech, Celltrion and Teva have a pending FDA submission for rheumatoid arthritis (RA), granulomatosis with polyangiitis (GPA), and microscopic polyangiitis (MPA), and a license from Genentech to expand the TRUXIMA label to include these indications in Q2 2020.”  Teva also disclosed that the “Wholesale Acquisition Cost (WAC or “list price”) for TRUXIMA will be 10 percent lower than the reference product.”

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