Amgen Reports Positive Phase III Results for Biosimilar of Humira
ABP 501, a biosimilar candidate for Humira, was shown to have a immunogenicity and efficacy profile comparable to that of the innovator product.
Amgen announced on Oct. 8, 2014 that its biosimilar for Humira (adalimumab) met the primary endpoints of equivalence for efficacy and safety in a Phase III study of patients with moderate-to-severe plaque psoriasis. Immunogenicity of ABP 501, Amgen’s product, was comparable to Humira. Humira has indications for psoriasis, rheumatoid arthritis, Crohn’s disease, ulcerative colitis, and other inflammatory conditions.
The study enrolled 350 patients; 174 received ABP 501 and 173 were given Humira. Three of the study participants were randomized but did not receive either medication. Psoriasis Area and Severity Index (PASI) percent improvement was evaluated at week 16, which measures redness (erythema), thickness (induration), and scaliness of the skin.
“Results from Amgen’s biosimilar Phase III plaque psoriasis study met the primary endpoint for efficiacy and showed comparable safety and immunogenicity to adalimumab, which further demonstrates the company’s commitment to provide patients with access to high-quality medications,” noted Sean E. Harper, MD, executive vice-president of research and development at Amgen, in a press release.
Humira captured $10.7 billion in sales last year. By 2018, EvaluatePharma predicts Humira to top the chart at nearly $13 billion in sales due to a 5% annual growth rate. However, patent protection in the United States for Humira will expire in 2016, which could affect those projections. Humira accounted for nearly 60% of AbbVie’s revenue in 2013.
There are currently more than 20 potential biosimilars for Humira in existence in various stages of production, according to a recent Thomson Reuters analysis. Sandoz and Samsung Bioepis Co. Ltd. are following closely behind; each has a product in Phase III of development.
Source: Amgen
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August 9th 2024BioPharm International® spoke with Zara Bukhari, a PhD scholar at the University of the Pacific, Stockton, CA, and co-author of the peer-review research paper, Biosimilars Drug Development: Advances in Technologies from Molecule Design to Clinical Trials, published in the July/August 2024 issue, about process development for biosimilars.
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