EMA Advisory Committee Recommends Samsung Bioepis’ Biosimilar
The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for Samsung Bioepis’ Benepal, a biosimilar version of Enbrel (etanercept), for treating rheumatoid arthritis, psoriatic arthritis, axial spondyloarthritis (ankylosing spondylitis and non-radiographic axial spondyloarthritis), and plaque psoriasis. This marks the first time the CHMP has adopted a positive opinion on an etanercept biosimilar.
The CHMP's positive opinion will now be referred to the European Commission, which will review and decide on the grant of a marketing authorization for Benepali. If a marketing authorization is granted, Benepali will be the first etanercept biosimilar to be approved in the European Union, according to Samsung Bioepis.
Samsung Bioepis was established in 2012 and has commercial agreements with Biogen and Merck to commercialize and distribute biosimilar products in immunology and oncology.
Source: Samsung Bioepis