Phase III data support biosimilarity of BOW-015 to Remicade

Privately-held US biotech firm EPIRUS Biopharmaceuticals, which is focused on the development and production of biosimilar products for major emerging markets, has announced positive Phase III data from a clinical trial comparing the firm’s infliximab molecule BOW-015 to Remicade (infliximab) for the treatment of rheumatoid arthritis (RA).

This study in severe RA patients was designed as an equivalence trial comparing BOW-015 to Remicade. BOW-015 achieved a week 16 ACR20 response rate of 89.8%, compared to 86.4% for Remicade. This outcome met its pre-specified statistical endpoint and was within a 15% equivalence margin at a 95% confidence interval. The ACR20 is the American College of Rheumatology criteria for clinical improvement in patients with rheumatoid arthritis, indicating a 20% improvement across a series of diagnostic parameters.