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Samsung Bioepis receives approval from the European Commission for the Enbrel Biosimilar, Benepali.
Samsung Bioepis, the joint venture between Biogen and Samsung BioLogics, announced on Jan. 16, 2016 that the company 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.
Benepali is the first etanercept biosimilar referencing Enbrel to be approved in the EU, making it the first subcutaneous anti-TNF biosimilar available. Anti-TNFs are the largest component of the EU biologics market, accounting for approximately $10 billion of all biologics sold.
The EC approval was based on a preclinical and clinical data package submitted to the European Medicines Agency by Samsung Bioepis. Confirmatory data from head-to-head Phase I and Phase III clinical trials compared Benepali to its reference product Enbrel.