Sandoz proposed biosimilars rituximab and etanercept recommended for approval in Europe

Company receives positive CHMP opinions for biosimilars rituximab and etanercept to treat immunological diseases. Biosimilar rituximab also recommended to treat blood cancers.

"We are proud to help patients in Europe with blood cancers and immunological diseases by improving their access to effective treatments through the potential approval of not just one, but two new Sandoz biosimilar medicines," said Mark Levick, Global Head of Development, Biopharmaceuticals, Sandoz. "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".

If approved, Sandoz 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.

If Sandoz biosimilar etanercept is approved, it may be used in all indications of the reference medicine, Enbrel, which are rheumatoid arthritis, axial spondyloarthritis (ankylosing spondylitis, non-radiographic axial spondyloarthritis), plaque psoriasis, psoriatic arthritis, Juvenile idiopathic arthritis and pediatric plaque psoriasis.

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 and etanercept to their respective reference medicines.