EC approves first Enbrel biosimilar

The European Commission approved Benepali etanercept ( SB4) from Samsung Bioepis Co. Ltd., a biosimilar of Enbrel etanercept. Samsung Bioepis said the drug is the first Enbrel biosimilar, and the first subcutaneous biosimilar of an anti-tumor necrosis factor (TNF) antibody, approved in the EU.

The EC approved Benepali to treat adults with moderate to severe rheumatoid arthritis, psoriatic arthritis, non-radiographic axial spondyloarthritis and plaque psoriasis. ...