Coherus Presents Study Results Demonstrating Equivalence of its CHS-0214 Biosimilar to Etanercept
REDWOOD CITY, Calif., June 10, 2016 (GLOBE NEWSWIRE) -- Coherus BioSciences, Inc. (Nasdaq: 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.
Except for the historical information contained herein, the matters set forth in this press release, including statements regarding Coherus' plans, potential opportunities, expectations, projections, goals, objectives, milestones, strategies, product pipeline, clinical studies, product development, release of data and the potential benefits of its products under development are forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995, including Coherus' ability to obtain marketing approval for CHS-0214. Such forward-looking statements involve substantial risks and uncertainties that could cause our clinical development programs, future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the uncertainties inherent in the clinical drug development process, including the regulatory approval process, the timing of our regulatory filings and other matters that could affect the availability or commercial potential of our biosimilar drug candidates, as well as possible patent litigation. Coherus undertakes no obligation to update or revise any forward-looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to Coherus' business in general, see Coherus' Annual Report on Form 10-Q for the quarter ended March 31, 2016, filed with the Securities and Exchange Commission on May 9, 2016 and its future periodic reports to be filed with the Securities and Exchange Commission.
Enbrel® is registered trademarks of Amgen Inc.