BioCentury
ARTICLE | Clinical News

Biosimilar infliximab regulatory update

June 6, 2016 7:00 AM UTC

The European Commission approved an MAA from Samsung Bioepis Co. Ltd. for Flixabi infliximab, a biosimilar of autoimmune drug Remicade infliximab. Flixabi, a chimeric mAb against tumor necrosis factor (TNF) alpha, is indicated to treat rheumatoid arthritis (RA), Crohn’s disease (CD), ulcerative colitis (UC), ankylosing spondylitis, psoriatic arthritis and psoriasis. Biogen, which has EU commercialization rights to Flixabi, plans to launch it “in the coming months.”

Flixabi is approved in Korea as Renflexis. A BLA for the product is under FDA review; Samsung Bioepis declined to disclose the PDUFA date. ...