The European regulator has approved the first biosimilar referencing etanercept*, making it the second biosimilar anti-TNF to reach the market.

The biosimilar marketed as Benepali is made by Samsung Bioepis, a joint venture between Samsung Biologics and Biogen. The company holds a commercialization partnership with MSD.

It has been approved in Europe  for the treatment of RA, psoriatic arthritis, axial spondyloarthritis and plaque psoriasis.

According to reports, Samsung has filed for approval of the biosimilar under the name ‘SB4’ in Australia.

*Etanercept is currently marketed in Australia by Pfizer under the brand name Enbrel.