Biogen and Samsung Bioepis receive EU approval for Benepali

Biogen and Samsung Bioepis have been granted European regulatory approval for Benepali, their new biosimilar therapy for inflammatory diseases.

The European Commission has approved the drug for the treatment of adults with moderate to severe rheumatoid arthritis, psoriatic arthritis, non-radiographic axial spondyloarthritis and plaque psoriasis. It will be made available in the coming weeks.

This represents the first biosimilar version of etanercept referencing the branded product Enbrel, making it the first subcutaneous anti-TNF biosimilar available in the region.

A preclinical submission leveraging sophisticated molecular analytics, technical development and manufacturing expertise was used to demonstrate that Benepali offers equivalent efficacy to Enbrel.

Dr Alpna Seth, senior vice-president and global head of the biosimilars business unit at Biogen, said: "Benepali, as the first etanercept biosimilar referencing Enbrel approved in the EU, can help expand access to treatment options for people affected by chronic inflammatory conditions."

The drug's development has been overseen by Samsung Bioepis, a joint venture between Samsung Biologics and Biogen established in 2012.