Coherus BioSciences, Inc. (NASDAQ:CHRS) Files An 8-K

Coherus BioSciences, Inc. (NASDAQ:CHRS) a leading pure-play, global biosimilar company with late-stage clinical products, today announced results from two pharmacokinetic (PK) studies involving CHS-0214, a biosimilar candidate to etanercept (Enbrel®).

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CHS-0214-06 (‘06 Study) was a Phase 1 pharmacokinetic bioequivalence (PK BE) study comparing CHS-0214 vs. European Union (EU) Enbrel. The ‘06 Study achieved the primary PK BE endpoint, as the 90% confidence intervals for the geometric mean ratio for the two groups was within 80% to 125% for all PK parameters.

CHS-0214-07 (‘07 Study) is an additional, non-pivotal, Phase 1 bridging study. As anticipated, this study provided additional relative bioavailability data for CHS-0214. As planned, Coherus is moving forward with pre-submission meetings, now expected in the first quarter 2017, to review the complete CHS-0214 program prior to filing. The planned marketing authorizations submissions will occur directly thereafter.

Coherus has successfully completed five clinical studies with CHS-0214 demonstrating similarity to Enbrel, including two pivotal Phase 3 studies in two separate indications and three PK studies. We look forward to discussing all data with EU regulators in the context of the overall program at the upcoming pre-submission meeting in preparation for the filing,” said Denny Lanfear, President and Chief Executive Officer of Coherus BioSciences.

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 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 in four therapeutic areas, oncology, immunology (anti-TNF), ophthalmology and multiple sclerosis. For additional information, please visit

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