FDA OKs Pfizer's Rituximab Biosimilar


Rituximab-pvvr (Ruxience, Pfizer) is approved for the treatment of non-Hodgkin lymphoma, chronic lymphocytic leukemia, and granulomatosis with polyangiitis and microscopic polyangiitis.

Officials with the FDA today approved the second biosimilar referencing Rituxan (rituximab), according to a press release.

Rituximab-pvvr (Ruxience, Pfizer) is approved to treat non-Hodgkin lymphoma (NHL), chronic lymphocytic leukemia (CLL), and granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA).

Specifically, the biosimilar is indicated for the treatment of adults with:

  • 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 particle 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 chemotherapy.
  • Previously untreated diffuse large B-cell, CD20-positive, B-cell NHL in combination with cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) chemotherapy.
  • Previously untreated diffuse large B-cell, CD20-positive NHL in combination with CHOP or other anthracycline-based chemotherapy regimens.
  • Previously untreated and previously treated CD20-positive CLL in combination with fludarabine and cyclophosphamide.
  • GPA and MPA in adult patients in combination with glucocorticoids.

The approval was based on comprehensive data, which demonstrated biosimilarity of rituximab-pvvr to the reference product. The REFLECTIONS B3281006 clinical comparative study found no clinically meaningful differences in safety or efficacy compared with Rituxan in patients with CD20-positive, low tumor burden follicular lymphoma.

“Rituximab became on the first monoclonal antibody (mAB) cancer treatments when it was initially approved by the FDA, representing a significant treatment advance and the only option available to oncologists and their patients for a period of time,” Jeff Sharman, MD, medical director for US Oncology Hematology Research, said in a statement. “With this FDA approval, clinicians have an additional treatment option that will help improve access to care for patients in need of anti-CD20 mAb therapy.”

Like the reference product, labeling for rituximab-pvvr includes a Boxed Warning about the increased risks of fatal infusion-related reactions, severe skin and mouth reactions, hepatitis B virus reactivation, and progressive multifocal leukoencephalopathy.


FDA Approves Pfizer’s Biosimilar, Ruxience (rituximab-pvvr) for Certain Cancers and Autoimune Conditions [news releases]. Pfizer. https://www.pfizer.com/news/press-release/press-release-detail/fda_approves_pfizer_s_biosimilar_ruxience_rituximab_pvvr_for_certain_cancers_and_autoimmune_conditions. Accessed July 23, 2019.

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