Amgen has announced positive results of a phase 3 study evaluating its investigational drug, ABP 501, a biosimilar candidate to AbbVie's fully human anti-tumor necrosis factor alpha monoclonal antibody, adalimumab, in patients with moderate-to-severe rheumatoid arthritis.
Amgen has announced positive results of a phase 3 study evaluating its investigational drug, ABP 501, a biosimilar candidate to AbbVie’s fully human anti-tumor necrosis factor alpha monoclonal antibody, adalimumab (Humira), in patients with moderate-to-severe rheumatoid arthritis (RA).
The randomized, double-blind, active-controlled study compared ABP 501 with adalimumab in 526 adults with moderate-to-severe RA. At 24 weeks, the research team found that the disease scores of RA patients treated with ABP 501 were clinically equivalent to those of patients who received adalimumab. The biosimilar candidate’s safety and immunogenicity were also deemed comparable with those of adalimumab.
“The positive results from Amgen's biosimilar phase 3 RA study showed clinical equivalence in efficacy, and comparable safety and immunogenicity, to adalimumab,” said Sean E. Harper, MD, executive vice president of Research and Development at Amgen, in a press release. “…Inflammation remains a core therapeutic area for Amgen, and we are committed to leveraging our long-term heritage in the space to deliver a portfolio of biosimilar and novel compounds that benefit patients worldwide.”
AbbVie’s Humira is currently approved in the United States for the treatment of RA, juvenile idiopathic, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, and plaque psoriasis.