Biosimilar Adalimumab Is Equivalent to Humira in Phase 3 Trial

FDA filing expected this year

Promising data for biosimilar adalimumab (GP2017, Sandoz/Novartis) have been presented at the American Academy of Dermatology meeting in Orlando, Florida. The phase 3 confirmatory efficacy, safety, and immunogenicity study met its primary endpoint, demonstrating that GP2017 had efficacy equivalent to that of the reference medication, Humira (AbbVie).

The randomized, double-blind, controlled, 51-week trial consisted of three treatment periods. During the first 17-week period, eligible patients with active but clinically stable moderate-to-severe chronic plaque psoriasis were randomly assigned to receive either GP2017 or Humira. During the second period, the patients were randomly reassigned to four groups; the first two groups continued with their originally assigned treatment, and other two groups were switched to alternating treatment every six weeks until week 35. During the third period, the patients received their initially assigned treatments up to week 51.

The study’s primary endpoint was the proportion of patients who achieved a 75% improvement at week 16, as measured by the Psoriasis Area and Severity Index (PASI). The results confirmed equivalent efficacy by demonstrating PASI 75 response rates of 67% for the proposed biosimilar adalimumab and 65% for Humira in patients with moderate-to-severe chronic plaque psoriasis.

Results at week 17 demonstrated similar safety and immunogenicity between GP2017 and Humira. Reported adverse events and the presence of antidrug antibodies were similar between the two treatments. Observed adverse events were in line with the reference medication’s known safety profile.

Sandoz plans to file biosimilar adalimumab with the FDA in 2017. The company also anticipates launching five biosimilars of major oncology and immunology biologics by 2020.

Source: Novartis; March 6, 2017.