Research shows biosimilar adalimumab meets efficacy of Humira
A phase 3 study met its primary endpoint of demonstrating that Sandoz’s GP2017, a proposed biosimilar adalimumab, has equivalent efficacy to Humira in treating moderate-to-severe chronic plaque psoriasis, according to results presented at the American Academy of Dermatology Annual Meeting in Orlando, Fla.
Primary endpoint of the 51-week, randomized, double-blind, controlled study was proportion of patients who achieved a Psoriasis Area and Severity Index (PASI) 75 score, achieving a 75% improvement by week 16. The study compared efficacy, safety and immunogenicity between GP2017 and the reference medicine, Humira (adalimumab, AbbVie).
The study consisted of three treatment periods, including the first 17-week treatment period, in which eligible patients with active, but clinically stable, moderate-to-severe chronic plaque psoriasis were randomized to receive either GP2017 or adalimumab, according to a press release from Novartis, parent company of Sandoz.
In the second treatment period, patients were re-randomized into four groups; the first two groups continued with their originally assigned treatment and other two switched to alternating treatment every six weeks until week 35. In the third treatment period, patients received their initially assigned treatment up to week 51, according to the release.
In the 16-week primary endpoint, there was a 67% PASI 75 response rate for GP2017 and 65% for adalimumab, according to the release.
There were similar safety and immunogenicity between GP2017 and adalimumab at week 17, with reported adverse events (AEs) and presence of anti-drug antibodies similar across both treatment groups, according to the release. The AEs were in line with adalimumab’s known safety, Novartis reported.
"Currently, it is estimated that as few as 5% of eligible psoriasis patients get the biologics they need," Mark Levick, MD PhD, global head of development, biopharmaceuticals, Sandoz, stated in the release. “We are pleased the data reinforce the potential of our biosimilar adalimumab, if approved, to be another treatment option for moderate-to-severe chronic plaque psoriasis and other inflammatory diseases.”