×
ADVERTISEMENT

AUGUST 27, 2019

FDA Approves Hadlima Biosimilar for RA, Other Inflammatory Condition

By SPC News Staff

The FDA approved adalimumab-bwwd (Hadlima, Samsung Bioepis), a biosimilar of adalimumab (Humira, AbbVie), to treat rheumatoid arthritis (RA), juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, adult Crohn’s disease, ulcerative colitis and plaque psoriasis.

The FDA approval was based on data derived from a randomized, double-blind, 52-week, phase 3 study, in which 544 patients with moderate to severe RA despite methotrexate therapy were randomly