US-based biopharmaceutical firm Amgen has reported positive results from its Phase III trial of biosimilar candidate ABP 501 compared with Humira (adalimumab) in patients with moderate-to-severe rheumatoid arthritis.
The company said that the randomised, double-blind, active-controlled trial met its primary and key secondary endpoints.
The trial’s primary endpoint compared the ACR20 measurements (20% or greater improvement in ACR assessment) at week 24 and it was seen that ACR20 was within the prespecified margin for ABP 501 compared to adalimumab, showing clinical equivalence.
The safety and immunogenicity of ABP 501 were comparable to adalimumab and the trial’s major secondary endpoints included ACR50, ACR70 and DAS 28-CRP.
The Phase III trial evaluated safety, efficacy and immunogenicity of ABP 501 compared to adalimumab in these patients who have an inadequate response to methotrexate (MTX).
A total of 526 patients were enrolled in the trial, which included a screening period of four weeks and a treatment period of 22 weeks, followed by a safety follow-up period through to week 26.
Out of the total patients, 264 were randomised to receive ABP 501 40mg subcutaneous (SC) every two weeks and the remaining 262 patients were given adalimumab 40mg SC every two weeks.
Amgen executive vice-president of Research and Development Sean Harper said: "The positive results from Amgen’s biosimilar Phase III rheumatoid arthritis study showed clinical equivalence in efficacy, and comparable safety and immunogenicity, to adalimumab.
"Amgen’s success on both our ABP 501 psoriasis and rheumatoid arthritis studies underscores our expertise in the research and development of high-quality biologic therapies.
"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."
ABP 501 is being developed as a biosimilar candidate to adalimumab, an anti-TNF-a monoclonal antibody, which is approved to treat inflammatory diseases in many countries.
Inflammatory diseases include rheumatoid arthritis, plaque psoriasis, polyarticular juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease and ulcerative colitis.