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Nov 04, 2013
 |  BC Week In Review  |  Clinical News  |  Clinical Results

CHS-0214: Pivotal trial data

A crossover pivotal trial in healthy volunteers showed that CHS-0214 met the primary endpoint of pharmacokinetic similarity to Enbrel etanercept as measured by peak plasma (Cmax) and area under the curve (AUC) concentrations. Coherus said the trial met U.S., EU, and Japanese regulatory requirements for clinical pharmacokinetic similarity. Specifically, the geometric mean ratios were 98% for CHS-0214 to Enbrel and were within the pre-specified 90% CI...

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