Sandoz, a Novartis division, and the pioneer and global leader in biosimilars, 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. 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.
"Currently, it is estimated that as few as five per cent of eligible psoriasis patients get the biologics they need" said Mark Levick, MD PhD, global head of development, biopharmaceuticals, Sandoz. "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" Levick continued.
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.
Sandoz is committed to increasing patient access to high-quality, life-enhancing biosimilars. It is the pioneer and global leader in biosimilars and currently markets three biosimilars worldwide. Sandoz has a leading biosimilar pipeline, with plans to file biosimilar adalimumab with the EMA and the FDA in 2017. Sandoz also plans to launch five biosimilars of major oncology and immunology biologics across key geographies by 2020. As a division of the Novartis Group, Sandoz is well-positioned to lead the biosimilars industry based on its experience and capabilities in development, manufacturing and commercialization.
The study (NCT02016105) is a phase 3 randomized, double-blind, controlled, 51-week study to compare efficacy, safety and immunogenicity between GP2017 and Humira. The study 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.