Samsung Bioepis’ Humira Biosimilar Hits Primary Endpoint in Phase 3 Trial

Samsung Bioepis’ investigational Humira biosimilar, SB5, demonstrated equivalence to the reference product in patients with moderate to severe rheumatoid arthritis despite methotrexate therapy in a pivotal Phase 3 clinical trial, the South Korean drugmaker said.

SB5 met its primary endpoint, showing improvement from baseline compared with AbbVie’s Humira (adalimumab) at week 24, based on the American College of Rheumatology 20 percent response criteria, Samsung Bioepis said.

Humira is approved in the U.S. to treat a range of autoimmune diseases, including rheumatoid arthritis, plaque psoriasis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease and ulcerative colitis.

Humira already faces competition in India where Zydus Cadila launched a biosimilar under the trade name Exemptia in December. Other companies developing biosimilars of Humira include Coherus, Amgen and Momenta Pharmaceuticals. — Jonathon Shacat