Biosimilar adalimumab regulatory update

EMA accepted for review an MAA from Samsung Bioepis Co. Ltd. for SB5, a biosimilar of Humira adalimumab from AbbVie Inc. (NYSE:ABBV, Chicago, Ill.). Samsung Bioepis declined to disclose 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.

Humira, a mAb against tumor necrosis factor (TNF) alpha, is approved in the EU to treat psoriasis, rheumatoid arthritis (RA), psoriatic arthritis, axial spondyloarthritis, ankylosing spondylitis, Crohn’s disease (CD), ulcerative colitis (UC), polyarticular juvenile idiopathic arthritis and hidradenitis suppurativa...