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.

No meaningful differences were observed in safety or immunogenicity. Complete details of the study, including secondary endpoints and full safety and immunogenicity data, will be released at an upcoming major medical meeting.