Amgen's Humira biosimilar hits main goal of Phase III study in psoriasis

Amgen said Wednesday that its biosimilar candidate ABP 501 met the primary endpoint of equivalence to AbbVie's Humira (adalimumab) in a Phase III study of patients with moderate-to-severe plaque psoriasis. Amgen noted that the results are the first late-stage data from its biosimilars programme, which includes six molecules, with the first expected to launch in 2017.

The study, which randomised 350 patients to receive ABP 501 or Humira, had a main goal of percent improvement from baseline to week 16 of treatment in the Psoriasis Area and Severity Index (PASI). According to Amgen, top-line results showed that at week 16, the PASI percent improvement from baseline was "within the prespecified equivalence margin" for ABP 501 compared to Humira, while safety and immunogenicity "were comparable."

Amgen noted that the trial is the first of two late-stage studies designed to form the basis of global regulatory submissions for ABP 501, which has the same amino acid sequence as Humira. AbbVie's product is approved in a number of markets for the treatment of several inflammatory diseases, including ankylosing spondylitis, Crohn's disease, plaque psoriasis, polyarticular juvenile idiopathic arthritis, psoriatic arthritis, rheumatoid arthritis and ulcerative colitis. Patents on Humira, which generated sales of $10.7 billion last year, start to expire in December 2016.

For related analysis, read ViewPoints: Amgen becomes first Big Pharma to unveil Phase III biosimilar antibody data, and for more information on the biosimilars market, see The Future of Biosimilars: mapping critical uncertainties and the impact of future events.

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