European Medicines Agency Recommends Market Authorization for First Etanercept Biosimilar

Approved Biosimilar Products  •  EMA News

On November 19, 2015, the European Medicines Agency’s (EMA) Committee for Medicinal products for Human Use (CHMP) recommended the granting of a market authorization for Benepali, a biosimilar intended for the treatment of rheumatoid arthritis, psoriatic arthritis, axial spondyloarthritis and plaque psoriasis.  This is the second biosimilar antibody drug that the EMA has recommended for market authorization.   The applicant for the product is Samsung Bioepis UK Limited, a joint venture between Samsung Biologics and Biogen.

Benepali is biosimilar to reference product Enbrel (etanercept), authorized for use in the EU in February 2000.  Once market authorization has been granted for Benepali, the biologic will still need to be formally approved by the European Commission under Directive 2001/83/EC and Directive 2004/27/EC on the Community Code relating to Medicinal Products for Human Use.

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