BioCentury
ARTICLE | Clinical News

Coherus reports PK data for Enbrel biosimilar

October 29, 2013 12:46 AM UTC

Coherus BioSciences Inc. (Redwood City, Calif.) said CHS-0214, its biosimilar of autoimmune drug Enbrel etanercept, met the primary endpoint of pharmacokinetic similarity to Enbrel in healthy volunteers as measured by peak plasma and area under the curve (AUC) concentrations. Coherus said the trial met U.S., EU, and Japanese regulatory requirements for clinical pharmacokinetic similarity. The company said the trial is one of two required for submitting a biosimilar regulatory application to most regulatory authorities. The company said it plans to start the second pivotal trial to evaluate the safety and efficacy of CHS-0214 "in the very near future," but declined to disclose details.

Last month, Coherus partnered with Baxter International Inc. (NYSE:BAX) to develop and commercialize a biosimilar of Enbrel in Europe, Canada, Brazil and other undisclosed markets. Coherus is already developing the biosimilar in Asia with Daiichi Sankyo Co. Ltd. (Tokyo:4568; Osaka:4568) (see BioCentury Extra, Sept. 3). ...