EMA reviewing Samsung Bioepis' Humira biosimilar

Samsung Bioepis Co. Ltd. said EMA accepted for review an MAA for SB5, a biosimilar of autoimmune drug Humira adalimumab from AbbVie Inc. (NYSE:ABBV).

Samsung Bioepis spokesperson Mingi Hyun declined to say whether the company is seeking SB5's approval for all of Humira's approved indications in the EU, and declined to comment on Samsung Bioepis' U.S. plans for the biosimilar. ...