Coherus BioSciences (CHRS) Completes Two Enbrel PK Studies
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Coherus BioSciences, Inc. (Nasdaq: CHRS) announced results from two pharmacokinetic (PK) studies involving CHS-0214, a biosimilar candidate to etanercept (Enbrel).
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.
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