EU approves Erelzi (biosimilar etanercept) for rheumatoid arthritis, axial spondyloarthritis, plaque psoriasis, psoriatic arthritis, juvenile idiopathic arthritis and pediatric plaque psoriasis- Sandoz

Sandoz announced that the European Commission (EC) has approved Erelzi (biosimilar etanercept) for use in Europe. Erelzi is approved for use in all indications of the reference medicine, Enbrel. Erelzi is approved for rheumatoid arthritis, axial spondyloarthritis (ankylosing spondylitis and non-radiographic axial spondyloarthritis), plaque psoriasis, and psoriatic arthritis, as well as juvenile idiopathic arthritis and pediatric plaque psoriasis. Erelzi is available in a pre-filled syringe and an auto-injector pen, SensoReady, which has been designed for patient safety, comfort, and convenience.

The EC approval was based on a comprehensive development program generating analytical, preclinical, and clinical - including pharmacokinetic (PK) - data. The program demonstrated that Erelzi matches its reference medicine in terms of safety, efficacy, and quality.