REDWOOD CITY, CA, USA I August 28, 2017 I Coherus BioSciences, Inc. (NASDAQ:CHRS), today reported topline results from the first of three ongoing pharmacokinetic bioequivalence (“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 (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.
About Coherus BioSciences, Inc.
Coherus is a leading pure-play, global biosimilar company that develops and commercializes high-quality therapeutics for major regulated markets. Biosimilars are intended for use in place of existing, branded biologics to treat a range of chronic and often life-threatening diseases, with the potential to reduce costs and expand patient access. Composed of a team of proven industry veterans with world-class expertise in process science, analytical characterization, protein production, sales & marketing and clinical-regulatory development, Coherus is positioned as a leader in the global biosimilar marketplace. Coherus is advancing three late-stage clinical products towards commercialization, CHS-1701 (pegfilgrastim biosimilar), CHS-1420 (adalimumab biosimilar) and CHS-0214 (etanercept biosimilar), as well as developing a robust pipeline of future products in four therapeutic areas, oncology, immunology (anti-TNF), ophthalmology and multiple sclerosis. For additional information, please visit www.coherus.com.
SOURCE: Coherus BioSciences
Post Views: 51
REDWOOD CITY, CA, USA I August 28, 2017 I Coherus BioSciences, Inc. (NASDAQ:CHRS), today reported topline results from the first of three ongoing pharmacokinetic bioequivalence (“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 (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.
About Coherus BioSciences, Inc.
Coherus is a leading pure-play, global biosimilar company that develops and commercializes high-quality therapeutics for major regulated markets. Biosimilars are intended for use in place of existing, branded biologics to treat a range of chronic and often life-threatening diseases, with the potential to reduce costs and expand patient access. Composed of a team of proven industry veterans with world-class expertise in process science, analytical characterization, protein production, sales & marketing and clinical-regulatory development, Coherus is positioned as a leader in the global biosimilar marketplace. Coherus is advancing three late-stage clinical products towards commercialization, CHS-1701 (pegfilgrastim biosimilar), CHS-1420 (adalimumab biosimilar) and CHS-0214 (etanercept biosimilar), as well as developing a robust pipeline of future products in four therapeutic areas, oncology, immunology (anti-TNF), ophthalmology and multiple sclerosis. For additional information, please visit www.coherus.com.
SOURCE: Coherus BioSciences
Post Views: 51
