Samsung Bioepis secures EC approval to market RA biosimilar Flixabi in EU

30 May 2016 (Last Updated May 30th, 2016 18:30)

Samsung Bioepis, a joint venture between Samsung BioLogics and Biogen, has secured approval from the European Commission (EC) to market rheumatoid arthritis (RA) biosimilar, Flixabi, in the European Union (EU).

Samsung Bioepis, a joint venture between Samsung BioLogics and Biogen, has secured approval from the European Commission (EC) to market rheumatoid arthritis (RA) biosimilar, Flixabi, in the European Union (EU).

Flixabi, an infliximab biosimilar referencing Remicadei, is used to treat both adults afflicted with RA, Crohn's disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis, and psoriasis.

It is also used for patients aged between six and 17 years suffering from severe, active Crohn's disease or severely active ulcerative colitis.

Infliximab, an immunosuppressant, forms the key element in the composition of Flixabi, a chimeric human urine monoclonal antibody that fuses with high affinity to both soluble and transmembrane forms of tumour necrosis factor a (TNFa), but not to lymphotoxin a (TNFß).

"The approval of Flixabi marks a major step forward for both Samsung Bioepis and Biogen."

Flixabi is the second anti-TNF biosimilar developed by Biogen, following the approval of benepali (etanercept), a biosimilar referencing Enbrelii.

Biogen biosimilars business unit senior vice-president and global head Alpna Seth said: "The approval of Flixabi marks a major step forward for both Samsung Bioepis and Biogen.

"It expands our anti-TNF portfolio and furthers Biogen's commitment to commercialising biosimilars of advanced biologics, while expanding cost-effective treatment options for patients living with chronic inflammatory conditions such as Crohn's disease and ulcerative colitis."

Samsung Bioepis submitted the preclinical and clinical data to gain the EC approval from head-to-head Phase I and III clinical trials to compare flixabi with remicade.

Last week, Biogen and AbbVie secured the US Food and Drug Administration (FDA) approval for their once-monthly, self-administered, subcutaneous treatment, Zinbryta (daclizumab), to address relapsing forms of multiple sclerosis (RMS).