Positive results found for biosimilar in treating psoriasis patients

The biosimilar candidate ABP 501 (Amgen) has proved to be successful in treating patients with moderate-to-severe plaque psoriasis, according to results from an initial phase 3 study. ABP 501 met its primary end point for efficacy.

The primary end point was the percent improvement seen in the Psoriasis Area and Severity Index (PASI) from baseline to week 16 of treatment. The PASI percent improvement at week 16 came within the prespecified equivalence margin for the biosimilar versus the anti-tumor necrosis factor (TNF)-α monoclonal antibody adalimumab (Humira, Abbott Laboratories). ABP 501 also was found to have both safety and immunogenicity comparable to that for adalimumab.

The phase 3, randomized, double-blind, active-controlled study was designed to evaluate the efficacy and safety of ABP 501 compared with that of adalimumab in 350 adult patients with moderate-to-severe plaque psoriasis. Patients were randomized to 40 mg of ABP 501 or adalimumab injected subcutaneously every 2 weeks.

Final efficacy assessments will be undertaken at week 50 of the study, with the study concluding at week 52. Patients with at least a 50% improvement in PASI scores at week 16 will continue in the study for up to the total 52 weeks and will be re-randomized: those on ABP 501 will continue to receive it, while patients on adalimumab will continue to receive it or be switched to receive ABP 501 in a 1:1 fashion.

This study is the first of two phase 3 studies, the results of which are intended to serve as the basis for global regulatory submission for this biosimilar candidate for adalimumab.

ABP 501’s active ingredient is an anti-TNF monoclonal antibody with the same amino acid sequence as that of adalimumab.

The anti-TNF-α agent adalimumab is approved for the treatment of several inflammatory diseases in different countries. Its indications included plaque psoriasis, rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, ulcerative colitis, and Crohn’s disease. Adalimumab will lose its patent protection in the United States in 2016.

The manufacturer of ABP 501 notes that such biosimilars have “the potential to increase patient access to vital medicines.” They currently have 6 biosimilar molecules in development. The company anticipates that its portfolio of these biosimilars will be launched beginning in 2017.

It is estimated that worldwide 125 million people suffer from psoriasis. Of this group, 80% have plaque psoriasis.

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