Phase III study of CHS 1420 (adalimumab Humira biosimilar) meets primary endpoint in psoriasis- Coherus BioSciences

Coherus BioSciences reported topline results from an ongoing Phase III clinical study of CHS 1420 (adalimumab Humira biosimilar) candidate in psoriasis. This study met its primary endpoint demonstrating similarity between CHS 1420 and Humira with respect to percentage of subjects achieving 75% improvement in psoriasis area and severity index (PASI-75) at Week 12. The 95% confidence intervals for the difference between treatment groups fell well within the prespecified margin.

Both CHS-1420 and Humira were similarly well tolerated with similar safety profiles in this study. This was a confirmatory, randomized, double-blind, active-control, parallel-group, 3-part study in patients with active, moderate to severe, chronic plaque psoriasis. In treatment period 2, half the subjects randomized to Humira will cross-over to CHS-1420, modeling a chronic patient�s transition to a biosimilar. Comparative safety, including immunogenicity, and durability of response to CHS-1420 and Humira at week 16 and 24 are key secondary endpoints. These data will be presented at an upcoming scientific conference. The full dataset through treatment period 2 will be available in Q4 2016 and included in the BLA submission to follow.