Epirus provides update on infliximab biosimilar (BOW015)

November 17, 2015 7:49 AM

EPIRUS Biopharmaceuticals, Inc., 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) 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 strong regulatory package for Europe, Canada and the United States.”

EPIRUS continues to compile a comprehensive data package that will serve as the basis for the global filing. The forthcoming global registration study will build on positive data from EPIRUS’ Phase 1 study in healthy volunteers conducted in the United Kingdom and Phase 3 study in active RA patients, which were presented at recent American College of Rheumatology (ACR) and European League Against Rheumatism (EULAR) meetings.

These data reinforce the pharmacokinetic, safety and efficacy profile for BOW015, which further demonstrate the biosimilarity between BOW015 and Remicade. To date, between the clinical and market experience, nearly 750 patients have been treated with BOW015.

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