Coherus BioSciences, announced the start of its Phase 3 trial of CHS-0214, an investigational etanercept biosimilar, in rheumatoid arthritis (RA). The Phase 3 trial is a randomised, double-blind, active-control, parallel-group, multicentre, global study in subjects with active RA who have demonstrated an inadequate response to methotrexate. The primary endpoint is ACR 20 at 24 weeks.

“The initiation of a CHS-0214 Phase 3 study is an important event for RA patients,” said Barbara Finck, M.D., chief medical officer of Coherus. “This trial of biosimilar etanercept advances our goal to expand access to this life-changing medication for patients with RA.”

“This trial marks our transition to a Phase 3 company,” said Denny Lanfear, chief executive officer of Coherus. “In concert with our partners, Daiichi Sankyo and Baxter, we are pleased to advance this product to the final stage of development.”

“Coherus brings complementary capabilities with the potential to support accelerated entry into the biosimilar market for Baxter,” said Ludwig Hantson, Ph.D., president of Baxter BioScience. “This important milestone reflects our commitment to providing high quality biosimilars for patients around the world.”