Novartis and Sandoz receive CHMP backing for biosimilar rituximab and etanercept

Novartis and Sandoz have announced that their new biosimilar versions of rituximab and etanercept have been recommended for European regulatory approval.

The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has adopted positive opinions recommending the approval of both therapies to treat the same indications as their respective reference medicines.

This would mean the new version of rituximab – which is based on the reference medicine MabThera – could be used to treat non-Hodgkin's lymphoma, chronic lymphocytic leukaemia, rheumatoid arthritis, granulomatosis with polyangiitis, and microscopic polyangiitis.

Meanwhile, etanercept – based on Enbrel – would be available for use by patients with rheumatoid arthritis, axial spondyloarthritis, plaque psoriasis, psoriatic arthritis, juvenile idiopathic arthritis and pediatric plaque psoriasis.

These recommendations were based on comprehensive development programmes in which the biosimilarity of the new products to their respective reference medicines was demonstrated.

Dr Mark Levick, global head of development for biopharmaceuticals at Sandoz, said: "Today's recommendations from the CHMP will not only benefit patients, but they demonstrate our leadership in biosimilars and the strength of the Sandoz and Novartis immunology and oncology portfolios."

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