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

Coherus BioSciences reported results from an ongoing 3-Part, Phase III clinical study of CHS 1420, (adalimumab biosimilar) candidate in psoriasis. As previously reported, 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 pre-specified margin. Results from Part 2 of the study focused on maintenance of response through Week 24.

At the start of Part 2 (Week 16), 80.3% of subjects in the CHS 1420 group and 77.5% of subjects in the HUMIRA group achieved PASI-75. In Part 2 (weeks 16-24), half of the subjects who were initially treated with HUMIRA were switched to CHS 1420, modeling a chronic patient�s transition to a biosimilar. In Part 2, maintenance of PASI-75 was similar across the 3 subsequent treatment groups: CHS-1420 followed by CHS 1420, HUMIRA followed by CHS 1420, and HUMIRA followed by HUMIRA. CHS 1420 and HUMIRA were similarly well tolerated in all groups during Part 2. Anti-drug antibody results are preliminary at this time, but have not identified any clinically significant differences between the treatment groups.