Look out, AbbVie: Here comes Amgen's Humira biosimilar
- Amgen's ABP501, a biosimilar version of Humira (adalimumab) that is still in development, performed well in phase III trials that evaluated the monoclonal antibody's efficacy and safety in treating moderate-to-severe plaque psoriasis, according to Amgen.
- Humira is one of the top-selling drugs in the world and indicated for a broad range of anti-inflammatory treatment purposes, including plaque psoriasis, rheumatoid arthritis, ankylosing spondylitis, Crohn's disease, and ulcerative colitis.
- The primary endpoint in the phase III study was the Psorasis Area and Severity Index (PASI) patient score. Psoriasis affects approximately 3% of the world's population.
With $11 billion in sales in 2013, Humira is one of the top-selling drugs in the world—and a target for companies hungry for a piece of the revenue pie. With Humira patent expiration less than two years away, Amgen and several other companies—including Sandoz, which also has a Humira biosimilar prototype in phase III development—are trying to replicate AbbVie's success.
Although the topline results announced by Amgen didn't go into much detail, the company outlined the study design. The 16-week, phase III, randomized, double-blind, active-controlled trial enrolled 350 patients. The trial will continue for some patients, with a target stop date at 52 weeks and efficacy assessments at 50 weeks.