Samsung and Biogen JV Get EU OK for Biosimilar of Enbrel
The joint venture between Biogen and Samsung BioLogics, Samsung Bioepis, has been granted European Commission (EC) approval for Benepali , an etanercept biosimilar referencing Enbrel. Benepali has been granted marketing authorization in the European Union (EU) for the treatment of adults with moderate to severe rheumatoid arthritis (RA), psoriatic arthritis, non-radiographic axial spondyloarthritis, and plaque psoriasis. Biogen intends to make Benepali available for patients in the coming weeks.
The companies say that Benepali is the first etanercept biosimilar referencing Enbrel to be approved in the EU, making it the first subcutaneous anti-TNF biosimilar available there.