Sandoz’s proposed biosimilar adalimumab (GP2017) shows equivalent efficacy to reference medicine, according to data presented at the American Academy of Dermatology (AAD) in Orlando, Florida.
The primary endpoint of the study was the proportion of patients who achieved a 75 percent improvement at Week 16, as measured by the Psoriasis Area and Severity Index (PASI). Data from the study confirmed equivalent efficacy by demonstrating PASI 75 response rates of 67 percent for proposed biosimilar adalimumab and 65 percent for the reference medicine in patients with moderate to severe, chronic plaque psoriasis.
Results at week 17 demonstrated similar safety and immunogenicity between GP2017 and the reference medicine. Reported adverse events and the presence of anti-drug antibodies were similar across both treatment groups. Observed adverse events were in line with the reference medicine’s known safety profile.
The study (NCT02016105) is a Phase 3 randomized, double-blind, controlled, 51-week study to compare efficacy, safety and immunogenicity between GP2017 and Humira®. It consists of three treatment periods. During the first 17-week treatment period, eligible patients with active, but clinically stable, moderate to severe chronic plaque psoriasis were randomized to receive either GP2017 or Humira®. In the second 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 period, patients received their initially assigned treatment up to week 51.
What's more, a comprehensive development program shows potential of GP2017 to treat inflammatory diseases, such as rheumatoid arthritis, inflammatory bowel disease and plaque psoriasis, the company reports.