Biosimilar to etanercept meets primary endpoint
REDWOOD CITY, CA, USA I June 10, 2016 I Coherus BioSciences, Inc. (CHRS), a leading pure-play, global biosimilars company with late-stage clinical products, today announced the release of study data demonstrating the equivalence of Coherus’ etanercept biosimilar (CHS-0214) to Enbrel® (etanercept), the reference product, with respect to efficacy as measured by the primary endpoint, ACR20 at 24 weeks.
The study data was released today at the European League Against Rheumatism Annual European Congress of Rheumatology held in London, United Kingdom.
As a part of the study, the research team conducted a randomized, double-blind, two-part study in patients with moderate to severe rheumatoid arthritis and an inadequate response to methotrexate and who were naïve to biologic therapies.
Results of the study demonstrated the equivalence of CHS-0214 to etanercept with respect to efficacy as measured by a primary endpoint. Additionally, secondary endpoints supported equivalence of CHS-0214 to etanercept. There were no clinically meaningful differences between CHS-0214 and etanercept with regard to safety and immunogenicity.
“We are very pleased by the results of this particular study as it relates to demonstrating the safety and efficacy of our etanercept biosimilar,” said Dr. Barbara Finck, Chief Medical Officer, Coherus BioSciences. “We look forward to continued positive results for this particular product as we move forward on the market approval pathway.”
About Coherus BioSciences, Inc.
Coherus is a leading pure-play global biosimilar platform 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 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-0214 (etanercept biosimilar) and CHS-1420 (adalimumab biosimilar), as well as developing a robust pipeline of future products, including CHS-5217 (bevacizumab biosimilar) and CHS-3351 (ranibizumab biosimilar). For additional information, please visit www.coherus.com.
SOURCE: Coherus Biosciences
Post Views: 146
Biosimilar to etanercept meets primary endpoint
REDWOOD CITY, CA, USA I June 10, 2016 I Coherus BioSciences, Inc. (CHRS), a leading pure-play, global biosimilars company with late-stage clinical products, today announced the release of study data demonstrating the equivalence of Coherus’ etanercept biosimilar (CHS-0214) to Enbrel® (etanercept), the reference product, with respect to efficacy as measured by the primary endpoint, ACR20 at 24 weeks.
The study data was released today at the European League Against Rheumatism Annual European Congress of Rheumatology held in London, United Kingdom.
As a part of the study, the research team conducted a randomized, double-blind, two-part study in patients with moderate to severe rheumatoid arthritis and an inadequate response to methotrexate and who were naïve to biologic therapies.
Results of the study demonstrated the equivalence of CHS-0214 to etanercept with respect to efficacy as measured by a primary endpoint. Additionally, secondary endpoints supported equivalence of CHS-0214 to etanercept. There were no clinically meaningful differences between CHS-0214 and etanercept with regard to safety and immunogenicity.
“We are very pleased by the results of this particular study as it relates to demonstrating the safety and efficacy of our etanercept biosimilar,” said Dr. Barbara Finck, Chief Medical Officer, Coherus BioSciences. “We look forward to continued positive results for this particular product as we move forward on the market approval pathway.”
About Coherus BioSciences, Inc.
Coherus is a leading pure-play global biosimilar platform 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 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-0214 (etanercept biosimilar) and CHS-1420 (adalimumab biosimilar), as well as developing a robust pipeline of future products, including CHS-5217 (bevacizumab biosimilar) and CHS-3351 (ranibizumab biosimilar). For additional information, please visit www.coherus.com.
SOURCE: Coherus Biosciences
Post Views: 146
