BioCentury
ARTICLE | Clinical News

Epirus reports Phase I data for Remicade biosimilar

January 4, 2013 12:51 AM UTC

Epirus Biopharmaceuticals Inc. (Boston, Mass.) reported Phase I data on Thursday for BOW015, the company's biosimilar version of autoimmune drug Remicade infliximab from Johnson & Johnson (NYSE:JNJ) and Merck & Co. Inc. (NYSE:MRK). In a double-blind, U.K. trial in 84 healthy male volunteers, a single 5 mg/kg infusion of BOW015 met the primary endpoint of bioequivalence to Remicade as measured by peak plasma concentration and area under the curve. Epirus said BOW015 also met the secondary endpoints of safety and immunogenicity. Data from an ex-U.S. Phase III trial of BOW015 to treat rheumatoid arthritis are expected in late 2013. Epirus said it plans to seek approval of BOW015 outside the U.S., but declined to provide details on a timeline. The company also declined to discuss plans for BOW015 in the U.S. ...