EU CHMP recommends Blitzima (rituximab biosimilar) to treat NHL, CLL, granulomatosis with polyangiitis and microscopic polyangiitis. - Celltrion

The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Blitzima, intended for the treatment of non-Hodgkin's lymphoma (NHL), chronic lymphocytic leukaemia (CLL), granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA). The applicant for this medicinal product is Celltrion Healthcare Hungary Kft.

Blitzima will be available as a 500 mg concentrate for solution for infusion. The active substance of Blitzima is rituximab, a monoclonal antibody (ATC code: L01XC02) that binds specifically to the transmembrane protein CD20 found on both malignant and normal B cells. In NHL and CLL, this promotes destruction of malignant B cells and thus controls tumour growth. In GPA and MPA, it reduces the levels of B cells involved in their pathogenesis. Blitzima 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 Blitzima has comparable quality, safety and efficacy to Mabthera.

Comment: Patent expiry dates for the originator drug, Rituxan/MabThera are 22 September 2016 in the USA and 12 November 2013 in the EU.