Posted by Michael Wonder on 22 Apr 2017
Sandoz proposed biosimilars rituximab and etanercept recommended for approval in Europe
21 April 2017 - Subject to EC approval, Sandoz market leadership position extended as the only company to have five approved biosimilars in Europe.
Sandoz announced today that the 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.
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 leukaemia, 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 paediatric plaque psoriasis.
