Truxima is a rituximab biosimilar. Rituximab is a chimeric mouse/human monoclonal antibody, and achieves its therapeutic effect in exactly the same way as the reference rituximab product. By binding to CD20, which is primarily found on the surface of malignant and normal B cells, Truxima induces cell death.1,2
Based on comprehensive supporting data, Truxima has received authorisation for use in the same indications as reference rituximab3.
- Diffuse large B-Cell lymphoma in combination with CHOP
- Previously untreated stage III-IV follicular lymphoma in combination with chemotherapy + maintenance therapy
- Relapsed/refractory follicular lymphoma in combination with chemotherapy + maintenance therapy
- Previously untreated chronic lymphocytic leukaemia in combination with chemotherapy
- Relapsed or refractory chronic lymphocytic leukaemia in combination with chemotherapy
- Severe, active rheumatoid arthritis in combination with methotrexate
- Severe, active granulomatosis with polyangiitis and microscopic polyangiitis in combination with glucocorticoids
The dosing and administration of Truxima are the same as the reference IV rituximab. For the full licensed indications please refer to the Truxima SPC.
- European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP). Summary of opinion (initial authorisation): Truxima®. EMA/CHMP/813387/2016. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/Summary_of_opinion_-_Initial_authorisation/human/004112/WC500218017.pdf
- European Medicines Agency (EMA). Truxima® (rituximab). European Public Assessment Report. Celltrion. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Public_assessment_report/human/004112/WC500222695.pdf
- Truxima® (rituximab) Summary of Product Characteristics. Available at: www.medicines.ie