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news.Amgen has reported positive results from its Phase III trial of biosimilar candidate ABP 501 in patients with moderate-to-severe plaque psoriasis.
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ABP 501 is being developed by the company as a biosimilar to adalimumab, an anti-TNF-a monoclonal antibody.
The trial evaluated the efficacy and safety of ABP 501 compared with Humira (adalimumab) in patients with moderate-to-severe plaque psoriasis.
It met its primary endpoint, which was the psoriasis area and severity index (PASI) percent improvement from baseline to week 16 of treatment.
The company said that at week 16, the PASI percent improvement from baseline was within the prespecified equivalence margin for ABP 501 compared to adalimumab.
Amgen Research and Development executive vice-president Sean Harper said results from the biosimilar Phase III plaque psoriasis study met the primary endpoint for efficacy and showed comparable safety and immunogenicity to adalimumab, which further demonstrates the company’s commitment to provide patients with access to high-quality medicines.
"We look forward to continuing to leverage our experience and expertise in biotechnology to bring biosimilars to patients," Harper said.
The trial was the first of two Phase III studies intended to form the basis for global regulatory submissions for ABP 501.
Adalimumab is currently approved in many countries to treat inflammatory diseases such as rheumatoid arthritis, plaque psoriasis (PsO), polyarticular juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease and ulcerative colitis.
Image: A person’s arm covered with plaque psoriasis. Photo: courtesy of Methoxyroxy