Date: 2017-03-02
Type of information: Results
phase:
Announcement: results
Company: Coherus Biosciences (USA - CA)
Product: CHS-1420 (biosimilar version of Humira® (adalimumab))
Action mechanism: monoclonal antibody/biosimilar product/TNF alpha inhibitor. CHS-1420 is a biosimilar version of the monoclonal antibody adalimumab (Humira®). Adalimumab specifically binds to tumor necrosis factor (TNF)-alpha. Samsung Bioepis has initiated a phase 3 study in psoriasis in 2015.
Disease:
Therapeutic area:
Country:
Trial details: CHS-1420-03 was a randomized, double-blind, parallel-group study in healthy subjects designed to assess the PK bioequivalence of CHS-1420 to that of 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.
Latest news: • On March 2, 2017, Coherus BioSciences announced that CHS-1420, its proposed biosimilar of adalimumab, met the primary endpoint in a clinical pharmacokinetic (PK) bioequivalence study that compared CHS-1420 to Humira® in healthy subjects. The study met the criteria for clinical PK similarity on all prospectively defined PK endpoints: maximum serum concentration (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 (AUC0-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 differential safety findings observed between the two agents in this study. “This is our second successful CHS-1420 PK study,” noted Denny Lanfear, President and Chief Executive Officer of Coherus. “Our ability to achieve these results gives us confidence that we can similarly complete future PK studies with modified formulations, anticipated to commence later in 2017.”
