Regulatory Decision Summary for Renflexis

This submission was submitted to support the authorization of Renflexis, a biosimilar to the Canadian authorized reference biologic drug, Remicade, based on an extensive comparative structural, functional, non-clinical, PK and clinical studies. PK similarity between Renflexis and Remicade was established in a Phase 1 study conducted in healthy volunteers as the 90% confidence intervals (CIs) for the ratios of geometric least squares (LS) mean of Renflexis to Remicade for the tested PK parameters were all within the acceptance margins of 80% to 125%. Comparable efficacy, safety and immunogenicity between the two products were also demonstrated in a Phase 3, randomized, double-blind, controlled study conducted in rheumatoid arthritis (RA) patients. Specifically, the primary efficacy analysis showed that the 95% CI of the difference in the American College of Rheumatology (ACR) 20% response criteria (ACR20) response rate at Week 30 was entirely contained within the pre-specified equivalence margin of ± 15%. Numerical differences in some adverse events and in anti-drug antibody (ADA) formation were reported between Renflexis and Remicade, but they are not considered to be clinically meaningful.

Overall, based on the totality of evidence derived from the comparative structural, analytical and functional, non-clinical and clinical data, similarity between Renflexis and Remicade has been demonstrated. Furthermore, the scientific rationale provided by the sponsor to support the authorization of Renflexis in each indication held by the reference biologic drug is considered adequate and is in line with Health Canadas biosimilar guidance document. Therefore, the benefit risk balance of Renflexis is considered favourable for the treatment of adult rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, plaque psoriasis, and adult and pediatric ulcerative colitis and Crohns disease including adult patients with fistulising Crohns disease.