CHS-0214: Completed Phase III enrollment
Coherus completed enrollment in the double-blind, international Phase III RaPsOdy (CHS-0214-04) trial comparing 50 mg subcutaneous CHS-0214 vs. 50 mg Enbrel etanercept in about 496 patients. The completion of enrollment in CHS-0214-04 and the Phase III RApsody (CHS-0214-02) trial of CHS-0214 to treat rheumatoid arthritis triggered a $35 million milestone payment to Coherus under a 2013 deal granting Baxter exclusive, worldwide rights to develop and commercialize a biosimilar of Enbrel outside the U.S., Japan and certain Caribbean and Latin American countries (see BioCentury, Sept. 9, 2013).
The first part of CHS-0214-04 is comparing twice-weekly CHS-0214 vs. twice-weekly Enbrel for 12 weeks. The second part is comparing weekly CHS-0214 vs. weekly Enbrel for 40 weeks. The trial enrolled patients with active chronic plaque psoriasis who are naive to systemic biologic therapy. ...