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Ruxience
Published
Product name
Ruxience
Active ingredient
Rituximab
Submission type
New biosimilar medicine
Decision
Approved
Decision date
Registration date
What this medicine was approved for
Ruxience (rituximab) was approved for the following therapeutic use:
Non-Hodgkin's lymphoma
Ruxience is indicated for treatment of patients with:
- CD20 positive, previously untreated, Stage III/IV follicular, B-cell non-Hodgkin's lymphoma,
- CD20 positive, relapsed or refractory low grade or follicular, B-cell non-Hodgkin's lymphoma,
- CD20 positive, diffuse large B-cell non-Hodgkin's lymphoma, in combination with chemotherapy.
Chronic lymphocytic leukaemia
Ruxience is indicated for the treatment of patients with CD20 positive chronic lymphocytic leukaemia (CLL) in combination with chemotherapy.
Rheumatoid arthritis
Ruxience in combination with methotrexate is indicated for the treatment of adult patients with severe, active rheumatoid arthritis who have had an inadequate response or intolerance to at least one tumour necrosis factor (TNF) inhibitor therapy.
Ruxience has been shown to reduce the rate of progression of joint damage as measured by x-ray when given in combination with methotrexate.
Granulomatosis with polyangiitis (Wegener's) (GPA) and Microscopic polyangiitis (MPA)
Ruxience in combination with glucocorticoids is indicated for the induction of remission in patients with severely active Granulomatosis with polyangiitis (GPA, also known as Wegener's granulomatosis) and Microscopic polyangiitis (MPA). The efficacy and safety of retreatment with Ruxience have not been established.
How this medicine works
Ruxience (rituximab) is a biosimilar medicine to MabThera (rituximab). Rituximab binds specifically to the antigen cluster of differentiation 20 (CD20), a transmembrane molecule located on precursor B and mature B lymphocytes. The antigen is expressed on > 95% of all B cell non-Hodgkin's lymphomas (NHL). CD20 (also known as human B lymphocyte-restricted differentiation antigen, Bp35) is a hydrophobic transmembrane protein with a molecular weight of approximately 35 kD. This non-glycosylated phosphoprotein is found on both normal and malignant B cells, but not on haematopoietic stem cells, progenitor B cells, normal plasma cells or other normal tissues. CD20 regulates (an) early step(s) in the activation process for cell cycle initiation and differentiation, and possibly functions as a calcium ion channel. CD20 does not internalise upon antibody binding and is not shed from the cell surface. This antigen does not circulate in the plasma. Thus, free antigen does not compete for rituximab binding. In rheumatoid arthritis (RA) the putative mechanism of action of rituximab involves the depletion of surface antigen-positive B lymphocytes from synovial tissue, with downstream effects potentially including reduced activation of T cells and the associated release of pro‑inflammatory cytokines.
Why the TGA approved or did not approve this medicine
The decision was based on quality (chemistry and manufacturing), nonclinical (pharmacology and toxicology), clinical (pharmacology, safety and efficacy) and risk management plan information submitted by the sponsor. The benefit-risk profile of Ruxience was considered favourable for the therapeutic use approved.
Sponsor