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news.Coherus BioSciences has 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.
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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.
"An essential global regulatory requirement is the completion of a clinical study directly comparing the originator and our biosimilar candidate establishing PK similarity," said Barbara Finck , M.D., Chief Medical Officer of Coherus.
"We are pleased to have achieved robust results which we believe represents a significant reduction in development program risk."
"Adalimumab is a very complex molecule. Achieving this clinical milestone further validates Coherus’ development platform and demonstrates our ability to advance biosimilars across our portfolio," said Denny Lanfear , President and Chief Executive Officer of Coherus.