Date: 2014-08-14
Type of
information: Results
phase:
Announcement: results
Company: Coherus BioSciences (USA - CA)
Product: CHS-1420 (biosimilar version of Humira® (adalimumab))
Action
mechanism: biosimilar/monoclonal antibody/TNF alpha inhibitor
Disease:
Therapeutic
area: Autoimmune diseases
Country:
Trial
details:
Latest
news:
- • On August 14, 2014,Coherus BioSciences announced that CHS-1420, its proposed biosimilar of adalimumab (Humira®), met the primary endpoint in a pivotal clinical pharmacokinetic (PK) similarity study that compared CHS-1420 to Humira® in healthy subjects. The parallel-group, single-dose study met the criteria for clinical PK similarity on all three required, prospectively defined, PK endpoints: maximum serum concentration (Cmax), area under the time-concentration curve from first to last time point measured (AUC0-t), and area under the time-concentration curve from first time point extrapolated to infinity (AUC0-inf), with all three geometric mean ratios fully within the 90% confidence interval from 80% to 125%. Both agents were well tolerated and there were no differential safety findings observed between the two agents in this study.
Is
general: Yes
