Biosimilar Drugs for Psoriatic Arthritis, Other Conditions, One Step Closer to Approval

JULY 15, 2016
Andrew Smith
The US Food and Drug Administration’s (FDA’s) Arthritis Advisory Committee recently voted unanimously to recommend the approval of biosimilars to adalimumab (Humira) and etanercept (Enbrel).
Committee members voted 26-0 in favor of ABP 501, an adalimumab biosimilar from Amgen, which is seeking indications for rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, adult Crohn’s disease, adult ulcerative colitis and plaque psoriasis.
The anti-tumor necrosis factor alpha (anti-TNFa) monoclonal antibody inside ABP 501 has the same amino acid sequence as the adalimumab antibody and the biosimilar is designed to be administered at the same dosage and in the same way as AbbVie’s blockbuster medication, which is expected to generate more than $15 billion in revenue this year.
Amgen conducted 2 phase 3 studies — 1 in patients with moderate-to-severe plaque psoriasis and 1 in patients with moderate-to-severe rheumatoid arthritis — to demonstrate safety and efficacy comparable to adalimumab. ABP 501 met its primary endpoints in both tests, demonstrating clinical equivalence to adalimumab as well as comparable safety and immunogenicity.
As part of the FDA’s abbreviated licensure pathway for biosimilars, Amgen also furnished nonclinical data and an analysis of a subgroup of psoriasis patients who transitioned successfully from adalimumab to ABP 501.
Several advisory committee members expressed some doubts at the meeting that trials on adult patients with rheumatoid arthritis and plaque psoriasis support the use of ABP 501 on juvenile patients or those with irritable bowel syndrome. On the whole, however, everyone agreed that the balance of evidence supported approval.

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