Sandoz proposed biosimilars rituximab and etanercept recommended for approval in Europe*

Sandoz receives positive CHMP opinions for biosimilars rituximab and etanercept to treat immunological diseases. Biosimilar rituximab also recommended to treat blood cancers Comprehensive data packages, confirming Sandoz biosimilars rituximab and etanercept match their respective reference medicines, were the basis for CHMP decisions Subject to EC** approval, Sandoz market leadership position extended as the only company to have five approved biosimilars in Europe Holzkirchen, April 21, 2017 - Sandoz, a Novartis division, and the pioneer and global leader in biosimilars, announced today that the Committee for Medicinal Products for Human Use (CHMP) has adopted positive opinions, separately recommending the approval of both Sandoz' biosimilar rituximab and biosimilar etanercept in Europe, to treat the same indications as their respective reference medicines. "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, MD PhD, 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.