November 15, 2021

The U.S. FDA has approved a new indication for Ruxience® (rituximab-pvvr), Pfizer’s biosimilar for Genentech and Biogen’s Rituxan® (rituximab).

  • Ruxience is now indicated for use in combination with methotrexate to treat adults who have moderately to severely active rheumatoid arthritis (RA) and have had an inadequate response to one or more tumor necrosis factor antagonists.
  • This new indication matches the FDA-approved RA indication held by Ruxience’s reference product, Rituxan.
  • Recommended dosing for Ruxience in the treatment of RA is two 1,000mg intravenous infusions separated by two weeks (one course) given every 16-24 weeks, based on clinical evaluation.
  • The FDA first approved Ruxience in 2019. The drug is also indicated to treat non-Hodgkin lymphoma, chronic lymphocytic leukemia, granulomatosis with polyangiitis (Wegener’s granulomatosis), and microscopic polyangiitis.
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