The European Commission (EC) granted marketing authorization in the European Union (EU) for FLIXABI ®, an infliximab biosimilar referencing Remicade ®i.
FLIXABI was developed by Samsung Bioepis, the joint venture between Samsung BioLogics and Biogen. FLIXABI is indicated for the treatment of adults with rheumatoid arthritis (RA), Crohn’s disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis, and psoriasis. Additionally, FLIXABI can be used in patients 6 to 17 years old with severe, active Crohn’s disease or severely active ulcerative colitis.
FLIXABI will be the second anti-TNF biosimilar to be manufactured and commercialized by Biogen in the EU. Earlier this year, Samsung Bioepis received approval for BENEPALI ® (etanercept), a biosimilar referencing Enbrel ®ii. Biogen has since launched BENEPALI in several countries across the EU. At an estimated $10Bn a year, iii anti-TNF therapies are among the EU’s largest drug expenditures. iv BENEPALI and FLIXABI will offer physicians alternatives that will drive meaningful savings across the EU.
“The approval of FLIXABI marks a major step forward for both Samsung Bioepis and Biogen. It expands our anti-TNF portfolio and furthers Biogen’s commitment to commercializing biosimilars of advanced biologics, while expanding cost-effective treatment options for patients living with chronic inflammatory conditions such as Crohn’s disease and ulcerative colitis,” said Alpna Seth, Ph.D., Senior Vice President and Global Head of the Biosimilars Business Unit at Biogen. “We are delighted to be the first company to bring two anti-TNF biosimilars to patients and physicians across Europe.”
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 54 vi,viii
- FLIXABI was well tolerated, with comparable safety, pharmacokinetics and immunogenicity to Remicade vi,viii