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Biogen, Samsung JV Announces Etanercept Biosimilar Referencing Enbrel, BENEPALI, Approved in EU


The joint venture between Biogen
(NASDAQ: BIIB) and Samsung BioLogics, Samsung Bioepis, has been granted
European Commission (EC) approval for BENEPALI® , an
etanercept biosimilar referencing Enbrel®i. 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.

BENEPALI is the first etanercept biosimilar referencing Enbrel to be
approved in the EU, making it the first subcutaneous anti-TNF biosimilar
available there. Anti-TNF's are the largest component of the EU
biologics market, accounting for approximately $10 billion of

See full press release


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