Coherus BioSciences completes PK studies of CHS-0214
Coherus BioSciences announced results from two pharmacokinetic studies involving CHS-0214, a biosimilar candidate to etanercept, Enbrel. CHS-0214-06 was a Phase 1 pharmacokinetic bioequivalence study comparing CHS-0214 vs. European Union 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 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.