EU CHMP recommends approval of GP 2013 (biosimilar rituximab) for follicular lymphoma and diffuse large B-cell lymphoma, chronic lymphocytic leukemia, rheumatoid arthritis, granulomatosis with polyangiitis, and microscopic polyangiitis- Sandoz

The Committee for Medicinal Products for Human Use (CHMP) has adopted positive opinions, separately recommending the approval of GP 2013 (biosimilar rituximab), from Sandoz, in Europe. If approved, biosimilar rituximab may be used in all indications of the reference medicine, MabThera, which are non-Hodgkin's lymphoma - follicular lymphoma and diffuse large B-cell lymphoma - chronic lymphocytic leukemia, rheumatoid arthritis, granulomatosis with polyangiitis, and microscopic polyangiitis.

The CHMP recommendations were based on two comprehensive development programs in which analytical, preclinical and clinical - including pharmacokinetic / pharmacodynamic - data were generated. The programs demonstrated biosimilarity of biosimilar rituximab to its respective reference medicines. Studies within the biosimilar rituximab development program included a pharmacokinetic/pharmacodynamic (PK/PD) trial in rheumatoid arthritis (ASSIST-RA)and a Phase III confirmatory safety and efficacy study in follicular lymphoma (ASSIST-FL).