As part of the submission, Samsung Bioepis provided a robust preclinical and clinical data package from head-to-head Phase 1 and Phase 3 clinical trials comparing FLIXABI with the reference product Remicade.v,vi Following biosimilar approval guidelines from the European Medicines Agency, the Phase 3 clinical trial for FLIXABI was performed to confirm equivalent efficacy, and to compare safety and immunogenicity with Remicade. The 54-week, double-blind, Phase 3 study was conducted in patients with moderate to severe RA despite methotrexate therapy. The primary end point was the American College of Rheumatology 20% (ACR20) response at week 30 in the per-protocol set (PPS).vii The primary end point for the study was met, with data showing that patients taking FLIXABI had an equivalent ACR20 response and a comparable safety profile to those taking Remicade.vi
- A total of 584 patients were randomized in a 1:1 ratio to either FLIXABI (N=291, 290 analyzed) or Remicade (N=293) vi
- The ACR20 response rate at week 30 in the PPS showed equivalence of FLIXABI to Remicade: 64.1% vs. 66.0%, respectively (adjusted difference −1.88%; 95% CI: −10.26% to 6.51%). The ACR20 response rate at week 54 in the PPS confirmed equivalent efficacy, with results showing 65.3% vs. 69.2%, respectively (adjusted difference 3.07%; 95% CI: −12.00% to 5.86%)vi,viii
- ACR20 response in the full analysis set at week 30 and week 54 also showed equivalence of FLIXABI to Remicade: 55.5% vs. 59.0%, respectively (adjusted difference 2.95%; 95% CI: −10.88% to 4.97%) at week 30 and 50.7% vs. 52.6%, respectively (adjusted difference 1.15%; 95% CI: −9.16% to 6.86%) at week 54vi,viii
- FLIXABI was well tolerated, with comparable safety, pharmacokinetics and immunogenicity to Remicadevi,viii
