Coherus Biosciences, Inc. last week announced that its proposed etanercept biosimilar molecule, CHS-0214, an investigational drug, met the primary endpoint of clinical pharmacokinetic similarity to Enbrel in a confirmatory clinical study in healthy subjects meeting US, EU, and Japanese regulatory requirements for clinical PK similarity.
Coherus recently announced an agreement with Baxter International, Inc. to develop and commercialize a biosimilar of the etanercept molecule for Europe, Canada, Brazil, and other markets. The company has an existing development collaboration with Daiichi Sankyo in Japan.
The two-period, cross-over study met the study acceptance criteria for clinical PK similarity on all three required endpoints: maximum serum concentration (Cmax), area under the time-concentration curve from first to last time point measured (AUC0-t), and area under the time-concentration curve from first time point to infinity (AUC0-inf). The geometric mean ratios were 98% of CHS-0214 to Enbrel and were fully within the pre-specified regulatory bounds for the 90% confidence interval for Cmax, AUC0-t, and AUC0-inf.
“This confirmatory clinical PK study is one of two clinical studies required for filing a biosimilar marketing application across most regulatory jurisdictions. We are pleased to have had such robust results, and in the very near future, we plan to start the second required pivotal study to demonstrate similar safety and efficacy to support eventual regulatory approval and licensure,” said Barbara Finck, MD, Chief Medical Officer of Coherus.
“Etanercept is a very complex and challenging molecule. Achieving this milestone demonstrates that Coherus’ scientific and development capabilities enable us to compete successfully in the global biosimilars market across our portfolio,” said Denny Lanfear, President and Chief Executive Officer of Coherus.,
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