Samsung Bioepis Humira Biosimilar Approved

FDA has approved a Samsung Bioepis BLA for Hadlima (adalimumab-bwwd), a biosimilar referencing Abbott’s Humira for treating rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, adult Crohn’s disease, ulcerative colitis and plaque psoriasis. Hadlima will be commercialized in the U.S. by Merck, and is expected to launch after 6/30/2023 under a licensing agreement with AbbVie, Samsung says.

FDA approval was based on data from a randomized, double-blind 52-week Phase 3 study involving 544 patients with moderate to severe rheumatoid arthritis despite methotrexate therapy. “Up to Week 52, the efficacy, safety and immunogenicity profiles remained comparable between all three treatment groups,” the company says. “There were no treatment emergent issues or clinically relevant immunogenicity precipitated by alternating subjects between treatments.”