Coherus and Baxalta announce positive Phase 3 results of etanercept biosimilar

November 11, 2015 10:58 AM

Coherus BioSciences, Inc. and Baxalta Incorporated announced that CHS-0214, a proposed biosimilar of Enbrel, met its primary endpoints in a confirmatory, double-blind, randomized, controlled, two-part Phase 3 study.

This on-going 52-week study is evaluating the efficacy and safety of CHS-0214 compared to Enbrel® in patients with moderate-to-severe chronic plaque psoriasis.

“We are pleased with this positive clinical outcome,” said Barbara Finck, M.D., Chief Medical Officer of Coherus. “CHS-0214 is an important option for patients requiring treatment with etanercept. If approved by regulatory agencies, CHS-0214 has the potential to offer patients a high-quality treatment option for conditions for which etanercept is indicated.”

“Achievement of this late-stage clinical milestone further validates the capabilities of our development platform in advancing biosimilar compounds toward approvals within regulated markets,” said Denny Lanfear, President and Chief Executive Officer of Coherus.

The efficacy endpoints were based on a Week 12 assessment of Psoriasis Activity Severity Index (PASI) scores. At Week 12, the primary endpoints, the mean percent change in PASI from baseline and the proportion of subjects achieving 75% improvement in PASI from baseline, were within the pre-specified margins for demonstrating equivalence of CHS-0214 compared to Enbrel. There were no clinically meaningful differences in the safety profiles of the products.

“We are encouraged by the data from this confirmatory study,” said Dagmar Rosa-Björkeson, Executive Vice President and President, Biosimilars, Baxalta. “Plaque psoriasis has a significant impact on a patient’s quality of life and self-perception, so early access to treatment is imperative. If approved, CHS-0214 would expand access of treatment options for patients with moderate-to-severe chronic plaque psoriasis.”

The study continues as planned until Week 52. The psoriasis study is one of two, large, Phase 3 confirmatory trials intended for inclusion in global marketing applications for CHS-0214. Results for the second Phase 3 study in patients with rheumatoid arthritis are expected in the first quarter of 2016.

Coherus and Baxalta initiated a collaboration to develop and commercialize CHS-0214 in September of 2013.

 

 

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