A Phase III study has shown that GP2017, which is manufactured by Sandoz, a unit of Novartis AG (ADR) (NYSE:NVS), has shown positive results as a Humira biosimilar. Data gleaned from the study shows that the biosimilar can be used to treat psoriasis that is in the moderate or severe stages. The results were presented in Orlando, Florida to an annual meeting of dermatologists.
The trial took a period of 51 weeks and it showed that at the 16th week, there was 75% improvement for the patients of psoriasis who took the biosimilar. Immunogenicity, safety and efficacy were the primary goals of the study.
The study was divided into three periods. In the first treatment period, patients who were eligible were given either adalimumab or GP2017. These two choices were randomly made with no preference for either.
In the next treatment period there was another random group of patients with four groups being formed this time round. Two groups were required to continue with the treatment that they had originally been assigned while the other two groups were given alternative treatments. This went on until the 35th week. The third treatment period saw patients getting the treatment they had received the first time and this continued until the 51st week.
Data taken at each of the different treatment periods showed that GP2017 had a PASI response rate of 67% at week 16 while adalimumab had a 65% PASI response rate. Similar immunogenicity and safety results between adalimumab and GP2017 were achieved at week 17. Both biosimilars presented adverse events that were almost the same.
If approved, GP2017 will widen the access to biologics to more patients suffering from psoriasis. At present, it is estimated that only about 5% of psoriaris patents receive the biologics needed.
“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,” said biopharmaceutical development head at Sandoz, Mark Levick.
On Tuesday shares of Novartis AG fell by 1.56% to close the day at $74.37.