BOW015: Phase III data

A double-blind, ex-U.S. Phase III trial in 189 patients with severe and active RA on stable doses of methotrexate showed that infusions of 3 mg/kg BOW015 met the primary endpoint of equivalence to Remicade infliximab in the proportion of patients achieving an ACR20 response at week 16 (89.8% vs. 86.4%). Epirus said the pre-specified equivalence margin was 23% and that it selected the margin in accordance with biosimilar guidelines in most emerging countries. There were no observed meaningful differences in safety or immunogenicity between treatment groups. The company also said it has completed a "full battery" of non-clinical analytics for BOW015, but did not disclose details. Next quarter, Epirus plans to submit its first regulatory application for BOW-015 in an undisclosed Asian country. Additional regulatory applications in Southeast Asian and Latin American countries are expected in 2014 and 2015. The company said it does not have immediate plans to submit regulatory applications in the U.S. or Europe. ...