EPIRUS Bio initiates late-stage study of Remicade biosimilar

• EPIRUS Biopharmaceuticals (NASDAQ:EPRS) commences its pivotal Phase 3 clinical trial, called UNIFORM, to demonstrate the bioequivalence of BOW015 to J&J's (JNJ) Remicade (infliximab) in rheumatoid arthritis (RA). The 58-week, double-blind, one-to-one randomized, comparator-controlled study will be conducted across sites in the U.S., Europe and Latin America. The primary endpoint is the proportion of patients achieving ACR20 (20% improvement in RA symptoms) at Week 16.
• The company plans to file global marketing applications in 2017 based on 30-week data.