Coherus Announces Results For Pharmacokinetic Bioequivalence Study For CHS-1420

(RTTNews) - Coherus BioSciences Inc. (CHRS) reported results from the first of three ongoing pharmacokinetic bioequivalence or "PK/BE" studies comparing CHS-1420, a proposed adalimumab ("Humira") biosimilar candidate versus European marketed Humira. The study met the criteria for clinical PK/BE on all prospectively defined endpoints: maximum serum concentration or Cmax, area under the time-concentration curve from first to last time point measured (AUC-0-last), and area under the time-concentration curve from first time point extrapolated to infinity (AUC-0-inf).

The 90% confidence intervals of the geometric mean ratios for all PK endpoints fell well within the bioequivalence boundaries of 80% to 125%. Both agents were well tolerated and there were no clinical meaningful differential adverse events observed between the two agents in this study.

This study was a randomized, single-blind, single-dose, parallel-group study in 216 healthy subjects designed to assess the PK/BE of CHS-1420 to that of European marketed Humira by comparing relative bioavailability after sub-cutaneous administration of a single 40 mg dose. The safety and tolerability of CHS-1420 was also evaluated.