Novartis Division Sandoz Announces Proposed Biosimilar Adalimumab Shown to have Equivalent Efficacy, Similar Safety Profile as Humira

Sandoz, a Novartis NVS division, and the pioneer and global leader in biosimilars, today presented data for its proposed biosimilar adalimumab (GP2017). The Phase 3 confirmatory efficacy, safety and immunogenicity study met its primary endpoint demonstrating GP2017 has equivalent efficacy to the reference medicine, Humira®[1]. Results were 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% 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% for proposed biosimilar adalimumab and 65% 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.