EPIRUS Biopharmaceuticals Provides Clinical Program Update on BOW015

EPIRUS Biopharmaceuticals, Inc.

today announced the completion of manufacturing process lock and readiness for initiation of its pivotal global registration study. EPIRUS plans to initiate a global registration study for BOW015 (infliximab, reference biologic Remicade®ii) in active Rheumatoid Arthritis (RA) patients in the United States, Europe and other markets in the first quarter of 2016. The company is on track for a harmonized global filing for marketing approval for BOW015 in 2017. "A foundational step in biosimilar development is process development and manufacturing process lock to establish biosimilarity and manage long term cost of goods," said Amit Munshi, president and chief executive officer, EPIRUS Biopharmaceuticals. "We believe the combination of the enhanced product profile and improved titers resulting from our recent process development efforts, the upcoming global registration study and the existing clinical and market experience, will create a