CHMP recommends Ituxredi( rituximab biosimilar)
The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Ituxredi, intended for the treatment of non-Hodgkin’s lymphoma (NHL), chronic lymphocytic leukaemia (CLL), rheumatoid arthritis, granulomatosis with polyangiitis and microscopic polyangiitis and pemphigus vulgaris
The applicant for this medicinal product is Reddy Holding GmbH.
Ituxredi will be available as a 100 mg and 500 mg concentrate for solution for infusion. The active substance of Ituxredi is rituximab, a monoclonal antibody antineoplastic agent (ATC code: L01X C02). Rituximab binds specifically to the transmembrane antigen CD20 on B lymphocytes, inducing cancer cell death via apoptosis.
Ituxredi is a biosimilar medicinal product. It is highly similar to the reference product MabThera (rituximab), which was authorised in the EU on 2 June 1998. Data show that Ituxredi has comparable quality, safety and efficacy to MabThera (rituximab).
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