Samsung Bioepis' biosimilar version of Enbrel approved in EU

Samsung Bioepis announced that the European Commission approved Benepali as the first biosimilar version of Amgen's Enbrel cleared in the region. The company said that the anti-TNF therapy, also known as SB4, is authorised for the treatment of rheumatoid arthritis, psoriatic arthritis, axial spondyloarthritis and plaque psoriasis.

In November, the European Medicines Agency's Committee for Medicinal Products for Human Use adopted a positive opinion on Benepali. Samsung Bioepis noted that in a Phase III study, Benepali demonstrated comparable safety and equivalent efficacy to Enbrel, as evidenced in ACR20 response rates of 80.8 percent and 81.5 percent, respectively.

Christopher Hansung Ko, CEO of Samsung Bioepis, a joint venture between Samsung Biologics and Biogen, remarked "in just under four years, we successfully developed, tested and obtained regulatory approval for Benepali." Samsung Bioepis indicated that Benepali will be "gradually rolled out" in Europe, with Biogen leading the marketing and distribution of the therapy under a 2013 deal.

Last year, Samsung Bioepis' biosimilar version of Enbrel gained approval in South Korea, where it is marketed by Merck & Co. under the name Brenzys. Samsung Bioepis is also planning to seek regulatory approval for the therapy in the US.

For more information on biosimilars, see The Future of Biosimilars 2015.

To read more Top Story articles, click here.