Generics and Biosimilars Initiative (GaBI) (05/22/2015)

A team of German researchers reviewed clinical trials for etanercept biosimilars as part of an investigation into biosimilars for the treatment of psoriasis. The review looked at randomized, controlled trials that compared etanercept biosimilars with the reference biological. One registered study of an etanercept biosimilar was being conducted in patients with psoriasis, and three were being carried out in patients with rheumatoid arthritis. No trials involved patients with ankylosing spondylitis, ulcerative colitis, Crohn's disease, or psoriatic arthritis. Meanwhile, one trial is looking at the etanercept biosimilar GP2015 for the treatment of psoriasis in about 270 patients. Still, the authors note that "inflammatory bowel diseases respond to infliximab and adalimumab but not to etanercept, whereas etanercept, on the other hand, is effective in psoriasis and rheumatoid arthritis," which they say "clearly underlines the differences between the various disorders." Thus, the researchers are cautious about exchanging reference drugs with biosimilars, which should be done only after "careful consideration," they write.

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