Success Seen for Amgen's ABP 501 for Psoriasis

Published: Oct 9, 2014

By Nancy Walsh, Senior Staff Writer, MedPage Today

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A phase III study comparing the biosimilar ABP 501 to the monoclonal antibody adalimumab (Humira) met its primary endpoint for the treatment of moderate-to-severe plaque psoriasis, manufacturer Amgenannounced.

That endpoint was percent improvement on the Psoriasis Area and Severity Index (PASI) at week 16 being "within the prespecified equivalence margin for ABP 501 compared to adalimumab," according to a statement by the company.

"The active ingredient of ABP 501 is an anti-TNF monoclonal antibody which has the same amino acid sequence as adalimumab," the company explained.

The double-blind study included 350 patients randomized to receive 40 mg of ABP 501 or adalimumab by subcutaneous injection every 2 weeks. Participants had to have had an inadequate response or couldn't tolerate at least one conventional systemic anti-psoriasis therapy.

At week 16, patients who have had at least 50% improvement in their PASI scores are being re-randomized, so that all those initially given the biosimilar will continue to do so and those originally on adalimumab will either continue on it or be switched to ABP 501 through week 50, when final efficacy evaluations will take place.

Adalimumab is an anti-tumor necrosis factor agent that is approved in many countries for rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, polyarticular juvenile idiopathic arthritis, plaque psoriasis, and Crohn's disease. It loses patent protection in the U.S. in 2016.

This trial is the first of two that are planned as the basis for global regulatory submissions for the biosimilar, according to the company.

"Results from Amgen's 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," said Sean E. Harper, MD, executive vice president of research and development at Amgen.

The company also is developing biosimilars to other biologics, including rituximab (Rituxan) and infliximab (Remicade).