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Biosimilars to rituximab, etanercept recommended for approval in Europe
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The Committee for Medicinal Products for Human Use has recommended approval of biosimilars by Sandoz for rituximab and etanercept for the same indications as the respective reference products.
“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,” Global Head of Development, Biopharmaceuticals at Sandoz, Mark Levick, MD, PhD, said in a company press release.
According to the release, the indications for rituximab (MabThera, F. Hoffmann-La Roche AG) — for which the biosimilar will be indicated — include non-Hodgkin’s lymphoma, for both follicular lymphoma and diffuse large B-cell lymphoma; chronic lymphocytic leukemia; rheumatoid arthritis (RA); granulomatosis with polyangiitis; and microscopic polyangiitis. Indications for etanercept (Enbrel, Pfizer in Europe and Amgen in the United States) include RA, axial spondyloarthritis — for both ankylosing spondylitis and non-radiographic axial spondyloarthritis — plaque psoriasis, psoriatic arthritis, juvenile idiopathic arthritis and pediatric plaque psoriasis.
The rituximab biosimilar development program included a pharmacokinetic/pharmacodynamic study in RA and a phase 3 safety and efficacy trial in follicular lymphoma. The etanercept biosimilar development program included a phase 3 safety and efficacy study in moderate to severe plaque psoriasis.
“Today’s recommendations from the [Committee for Medicinal Products for Human Use] 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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