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Coherus Announces Positive Topline Results for CHS-1701 (Pegfilgrastim Biosimilar Candidate) Pharmacokinetic and Pharmacodynamic Biosimilarity Study

REDWOOD CITY, Calif., July 11, 2016 (GLOBE NEWSWIRE) -- Coherus BioSciences, Inc. (CHRS), a leading global biosimilars company with late-stage clinical products, today reported topline results from its follow-on pharmacokinetic and pharmacodynamic (PK/PD) clinical study of CHS-1701, a pegfilgrastim (Neulasta®) biosimilar candidate. This study met all of its co-primary endpoints for PK, Cmax and Area Under the Curve (AUC), and PD, absolute neutrophil count, and ANC (ANCmax and ANC AUC). For both endpoints, the 90% Confidence Intervals (CI) for the Geometric Mean Ratio (GMR) were well contained within the pre-specified margins of 80% to 125%.

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This randomized, single-blind, three-sequence, three-period crossover study in healthy subjects assessed PK, PD, and safety (including immunogenicity) of a 6 mg subcutaneous (SC) injection of CHS-1701 compared to 6 mg SC dose of Neulasta. A total of 122 healthy volunteer subjects were randomized to one of three treatment sequences, each with three treatments. Subject inclusion criteria, procedures and study design, as well as other measures, reflected modifications addressing findings in the previous study CHS-1701-03, successfully decreasing subject variability and eliminating the extreme subject outliers previously observed.

“As has been seen, pegfilgrastim is a relatively biologically complex molecule. Our novel and innovative study design allowed us to evaluate and successfully control for the contribution of subject variability to the PK/PD parameters, validating our hypothesis regarding the outliers seen in the earlier study. Based on the totality of the data, including this clinical result as well as those from the previous PK/PD study and the successful immunogenicity study, we are confident that CHS-1701 is highly biosimilar to the reference product, Neulasta, and will produce the expected clinical effect in patients, said...