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Coherus and Baxalta announce that a Phase 3 clinical trial comparing their biosimilar candidate to Amgen's Enbrel (etanercept), CHS-0214, in patients with rheumatoid arthritis met its primary endpoint of demonstrating equivalence

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Additional Relevant Details The primary efficacy endpoint was the proportion of subjects achieving ACR20 (20% improvement according to the American College of Rheumatology criteria) at Week 24. The primary endpoint was within the pre-specified margins for demonstrating equivalence of CHS-0214 compared to Enbrel. There were no clinically meaningful differences in the safety and immunogenicity profiles of the two products. This rheumatoid arthritis study is the second of two, large, Phase 3 confirmatory trials intended for inclusion in global marketing applications for CHS-0214. Results for the first Phase 3 study in patients with chronic plaque psoriasis were released in November 2015 and showed that this first study also met its primary endpoints.
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Occurred on:
Jan 11, 2016
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Related Keywords Biosimilar, Enbrel, Etanercept, Phase 3 Study In Pancreatic Cancer, Rheumatoid Arthritis, Ra