EU approval for Benepali (etanercept biosimilar) to treat RA, PsA, psoriasis and axial spondyloarthritis- Biogen + Samsung Bioepis
The joint venture between Biogen and Samsung BioLogics, has been granted European Commission (EC) approval for Benepali, an etanercept biosimilar referencing Enbrel. Benepali has been granted marketing authorisation 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 Enbrel to be approved in the EU, making it the first subcutaneous anti-TNF biosimilar available there. Anti-TNFs are the largest component of the EU biologics market.
Comment: Enbrel patents cover etanercept until 2018 in the US and expired in August 2015 in the EU.
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