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Biosimilar Candidate Is Equivalent to Adalimumab in Phase III Arthritis Trial
A phase III study evaluating the efficacy and safety of a biosimilar candidate, ABP 501, compared with that of adalimumab (Humira, AbbVie) in patients with moderate-to-severe rheumatoid arthritis (RA) has met its primary and key secondary endpoints.
The trial’s primary endpoint compared ACR20 measurements (a 20% or greater improvement in the American College of Rheumatology [ACR] assessment) at week 24. The ACR20 was within the prespecified margin for ABP 501 compared with adalimumab, showing clinical equivalence. The safety and immunogenicity of ABP 501 were comparable with that of adalimumab.
ABP 501 is being developed as a biosimilar candidate to adalimumab, an anti-tumor necrosis factor-alpha (TNF-alpha) monoclonal antibody, which is approved in many countries for the treatment of inflammatory diseases, including RA, plaque psoriasis, polyarticular juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, and ulcerative colitis.
The drug’s developer (Amgen) has nine biosimilar molecules in development and expects to launch five of these biosimilars between 2017 and 2019.
The randomized, double-blind, active-controlled study evaluated the safety, efficacy, and immunogenicity of ABP 501 compared with that of adalimumab in adult patients with moderate-to-severe RA who had shown an inadequate response to methotrexate. The study consisted of a screening period of 4 weeks and a treatment period of 22 weeks, followed by a safety follow-up period to week 26. A total of 526 patients were enrolled. Among them, 264 patients were randomly assigned to receive subcutaneous (SC) ABP 501 40 mg every 2 weeks, and 262 patients received SC adalimumab 40 mg every 2 weeks. The primary endpoint was the assessment of ACR20 at week 24.
RA is a chronic inflammatory disease of unknown etiology in which patients exhibit sytemic features, such as fatigue, low-grade fever, weight loss, anemia, and increased systemic levels of acute-phase reactants (e.g., erythrocyte sedimentation rate [ESR] and C-reactive protein [CRP]).
The active ingredient of ABP 501 is an anti-TNF-alpha monoclonal antibody that has the same amino acid sequence as adalimumab. ABP 501 also has the same pharmaceutical dosage form and strength as adalimumab.
Source: Amgen; February 3, 2015.