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Truxima (rituximab)

Biosimilar
Region
🇪🇺 EU
Active substance
rituximab
Company
Celltrion Healthcare Hungary Kft.
Status
Authorised
Therapeutic area
Lymphoma, Non-Hodgkin; Arthritis, Rheumatoid; Wegener Granulomatosis; Leukemia, Lymphocytic, Chronic, B-Cell; Microscopic Polyangiitis
CHMP opinion
Thu 15 Dec 2016
EU approval
Fri 17 Feb 2017
Designations
Biosimilar
Application
EMEA/H/C/004112
ATC
L01FA01
Official record
www.ema.europa.eu

Indication

Truxima is indicated in adults for the following indications: Non-Hodgkin’s lymphoma (NHL) Truxima is indicated for the treatment of previously untreated patients with stage III IV follicular lymphoma in combination with chemotherapy. Truxima maintenance therapy is indicated for the treatment of follicular lymphoma patients responding to induction therapy. Truxima monotherapy is indicated for treatment of patients with stage III IV follicular lymphoma who are chemo resistant or are in their second or subsequent relapse after chemotherapy. Truxima is indicated for the treatment of patients with CD20 positive diffuse large B cell non Hodgkin’s lymphoma in combination with CHOP (cyclophosphamide, doxorubicin, vincristine, prednisolone) chemotherapy. Chronic lymphocytic leukaemia (CLL) Truxima in combination with chemotherapy is indicated for the treatment of patients with previously untreated and relapsed/refractory CLL. Only limited data are available on efficacy and safety for patients previously treated with monoclonal antibodies including Truxima or patients refractory to previous Truxima plus chemotherapy. Rheumatoid arthritis Truxima 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 other disease modifying anti rheumatic drugs (DMARD) including one or more tumour necrosis factor (TNF) inhibitor therapies. Truxima has been shown to reduce the rate of progression of joint damage as measured by X ray and to improve physical function, when given in combination with methotrexate. Granulomatosis with polyangiitis and microscopic polyangiitis Truxima, in combination with glucocorticoids, is indicated for the treatment of adult patients with severe, active granulomatosis with polyangiitis (Wegener’s) (GPA) and microscopic polyangiitis (MPA). Pemphigus vulgaris Truxima is indicated for the treatment of patients with moderate to severe pemphigus vulgaris (PV).

Regulatory milestones

No milestones recorded in the last year.

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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.