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Ruxience
Sponsor
ARTGs
330536, 330537
330536, 330537
Device/Product name
Ruxience
Active Ingredient
Rituximab
Date of decision
Published
Submission type
New biosimilar medicine
ATC codes
L01XC02
Decision
Approved
What was the decision based on
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.
What steps were involved in the decision process
Registration timeline
The following table summarises the key steps and dates for this application.
| Description | Date |
|---|---|
| Submission dossier accepted and first round evaluation commenced | 6 April 2020 |
| First round evaluation completed | 28 August 2020 |
| Sponsor provides responses on questions raised in first round evaluation | 2 November 2020 |
| Second round evaluation completed | 10 December 2020 |
| Delegate's overall benefit-risk assessment | 3 February 2021 |
| Sponsor's pre-Advisory Committee response | Not applicable |
| Advisory Committee meeting | Not applicable |
| Registration decision (Outcome) | 26 February 2021 |
| Completion of administrative activities and registration on ARTG | 3 March 2021 |
| Number of working days from submission dossier acceptance to registration decision* | 188 |
*Statutory timeframe for standard applications is 255 working days
Date of entry onto ARTG
Original publication date
Black triangle scheme
No
Dose forms
Concentrate for solution for infusion
Strength
100 mg/10 mL, 500 mg/50 mL
Other ingredients
Histidine, histidine hydrochloride monohydrate, disodium edetate, polysorbate 80, sucrose, water for injection
Containers
Vial
Pack sizes
One
Routes of administration
Intravenous infusion
Dosage
In order to improve traceability of biological medicinal products, the trade name and the batch number of the administered product should be clearly recorded in the patient dispensing record.
Ruxience intravenous formulation is not intended for subcutaneous (SC) administration.
Ruxience may be administered in an outpatient setting. Ruxience should be administered as an intravenous infusion in an environment where full resuscitation facilities are immediately available, and under the close supervision of an experienced healthcare professional.
Dosage of Ruxience depends on multiple factors, including the condition being treated. For further information on dosage, refer to the Product Information.
Pregnancy category
CDrugs which, owing to their pharmacological effects, have caused or may be suspected of causing, harmful effects on the human fetus or neonate without causing malformations. These effects may be reversible. Accompanying texts should be consulted for further details.The use of any medicine during pregnancy requires careful consideration of both risks and benefits by the treating health professional. This must not be used as the sole basis of decision making in the use of medicines during pregnancy. The TGA does not provide advice on the use of medicines in pregnancy for specific cases. More information is available from obstetric drug information services in your State or Territory.
What was approved
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.
What is this medicine and how does it work
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.
What post-market commitments will the sponsor undertake
- The Ruxience European Union (EU)-Risk Management Plan (RMP) (version 1.0, dated 18 December 2019, data lock point 18 May 2018), with Australian specific Annex (version 3.0, dated 11 January 2021), included with submission PM-2020-00593-1-6, and any subsequent revisions, as agreed with the TGA will be implemented in Australia.
An obligatory component of risk management plans is routine pharmacovigilance. Routine pharmacovigilance includes the submission of periodic safety update reports (PSURs).
Reports are to be provided in line with the current published list of EU reference dates and frequency of submission of PSURs until the period covered by such reports is not less than three years from the date of the approval letter.
The reports are to at least meet the requirements for PSURs as described in the European Medicines Agency's Guideline on Good Pharmacovigilance Practices (GVP) Module VII periodic safety update report (Rev 1), Part VII.B Structures and processes. Note that submission of a PSUR does not constitute an application to vary the registration.
- For all injectable products the Product Information must be included with the product as a package insert.